Trial Outcomes & Findings for Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device (NCT NCT02186561)

Last Updated: 2019-12-27

Results Overview

The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

Recruitment status

COMPLETED

Study phase

Target enrollment

197 participants

Primary outcome timeframe

Up to 12 Months Post Procedure

Results posted on

2019-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	PREMIER The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Enrollment STARTED	197
Enrollment COMPLETED	141
Enrollment NOT COMPLETED	56
Subjects Implanted With Device STARTED	141
Subjects Implanted With Device COMPLETED	141
Subjects Implanted With Device NOT COMPLETED	0
30-Day Post Index Procedure Visit STARTED	141
30-Day Post Index Procedure Visit COMPLETED	140
30-Day Post Index Procedure Visit NOT COMPLETED	1
180- Day Post Index Procedure Visit STARTED	141
180- Day Post Index Procedure Visit COMPLETED	134
180- Day Post Index Procedure Visit NOT COMPLETED	7
1- Year Post Index Procedure Visit STARTED	141
1- Year Post Index Procedure Visit COMPLETED	139
1- Year Post Index Procedure Visit NOT COMPLETED	2
2 - Year Post Index Procedure Visit STARTED	141
2 - Year Post Index Procedure Visit COMPLETED	134
2 - Year Post Index Procedure Visit NOT COMPLETED	7
3 - Year Post Index Procedure Visit STARTED	141
3 - Year Post Index Procedure Visit COMPLETED	128
3 - Year Post Index Procedure Visit NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	PREMIER The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Enrollment Did Not Meet Inclusion Criteria	46
Enrollment Enrollment Cap Reached	5
Enrollment Insurance Denial	2
Enrollment Withdrawal by Subject	2
Enrollment Investigator Withdrew Consent	1
30-Day Post Index Procedure Visit Death	1
1- Year Post Index Procedure Visit Death	1
1- Year Post Index Procedure Visit Missed	1

Baseline Characteristics

Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PREMIER n=141 Participants The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
Age, Continuous	54.6 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	124 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	114 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants
Region of Enrollment United States	135 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 Months Post Procedure

Population: Participants enrolled and implanted with the Investigational Device (ITT)

Outcome measures

Outcome measures
Measure	PREMIER n=141 Participants The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure	2.17 percentage of participants

PRIMARY outcome

Timeframe: Up to 12 Months Post Procedure

Population: Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging

The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.

Outcome measures

Outcome measures
Measure	PREMIER n=141 Participants The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure	76.71 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 30 days, Post Procedure

Population: Participants Treated with the Investigational Device that Completed the 30 Day Visit

Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.

Outcome measures

Outcome measures
Measure	PREMIER n=141 Participants The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications	0 Participants

SECONDARY outcome

Timeframe: > 30 days, Post Procedure

Population: ParticipantsTreated with the Investigational Device that Completed the 30 Day Visit

For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.

Outcome measures

Outcome measures
Measure	PREMIER n=141 Participants The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure	1 Participants

SECONDARY outcome

Timeframe: Index Procedure

Population: Participants Enrolled who Underwent the Index Procedure

The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.

Outcome measures

Outcome measures
Measure	PREMIER n=141 Participants The investigational device was implanted in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including the posterior inferior cerebellar artery to treat unruptured, wide-necked, aneurysms measuring ≤ 12 mm.
The Number of Participants With Successfully Deployed Investigational Device	140 Participants

Adverse Events

CEC Adjudicated Adverse Events Through 1-Year

Serious events: 39 serious events

Other events: 107 other events

Deaths: 1 deaths

CEC Adjudicated Adverse Events Through 2-Year

Serious events: 49 serious events

Other events: 112 other events

Deaths: 1 deaths

CEC Adjudicated Adverse Events Through 3-Year

Serious events: 60 serious events

Other events: 112 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Project Manager, Clinical Project Management

Medtronic Neurovascular, Clinical Affairs

Phone: 949-680-1274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	CEC Adjudicated Adverse Events Through 1-Year n=141 participants at risk Participants who received the Investigational Device followed through 1 Year	CEC Adjudicated Adverse Events Through 2-Year n=141 participants at risk Participants who received the Investigational Device followed through 2 Year	CEC Adjudicated Adverse Events Through 3-Year n=141 participants at risk Participants who received the Investigational Device followed through 3 Year
Blood and lymphatic system disorders Anaemia	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Cardiac disorders Atrial flutter	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Cardiac disorders Cardiac failure congestive	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Cardiac disorders Coronary Artery Disease	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Cardiac disorders Ventricular tachycardia	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Vision Blurred	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Abdominal pain	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Gastrointestinal haemorrhage	2.1% 3/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Nausea	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Pancreatitis	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Peritoneal haemorrhage	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Adverse drug reaction	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Chest pain	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Thrombosis in Device	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Hepatobiliary disorders Cholecystitis	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Hepatobiliary disorders Portal vein thrombosis	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Immune system disorders Anaphylactic reaction	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Colonic abscess	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Diverticulitis	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Gastroenteritis	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Influenza	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Pneumonia	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Wound Infection	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Patella Fracture	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Procedural hypertension	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Metabolism and nutrition disorders Dehydration	0.71% 1/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Compartment syndrome	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Carotid Artery Dissection	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Carotid artery stenosis	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Cerebral Haemorrhage	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.8% 4/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.8% 4/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Cerebral Infarction	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Convulsion	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Headache	2.8% 4/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	3.5% 5/141 • Number of events 6 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	4.3% 6/141 • Number of events 7 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Ischaemic stroke	2.1% 3/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)

Other adverse events
Measure	CEC Adjudicated Adverse Events Through 1-Year n=141 participants at risk Participants who received the Investigational Device followed through 1 Year	CEC Adjudicated Adverse Events Through 2-Year n=141 participants at risk Participants who received the Investigational Device followed through 2 Year	CEC Adjudicated Adverse Events Through 3-Year n=141 participants at risk Participants who received the Investigational Device followed through 3 Year
Blood and lymphatic system disorders Haemorrhagic Diathesis	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Blood and lymphatic system disorders Lymphoid tissue hyperplasia	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Ear and labyrinth disorders Vertigo	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Ear and labyrinth disorders Vertigo positional	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Amaurosis Fugax	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Blepharospasm	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Conjunctival Haemorrhage	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Diplopia	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Eye pain	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Photophobia	0.71% 1/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Photopsia	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	1.4% 2/141 • Number of events 2 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Vision blurred	5.0% 7/141 • Number of events 7 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	5.7% 8/141 • Number of events 8 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	5.7% 8/141 • Number of events 8 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Visual impairment	10.6% 15/141 • Number of events 15 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	12.1% 17/141 • Number of events 17 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	12.1% 17/141 • Number of events 17 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Vitreous detachment	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Eye disorders Vitreous floaters	3.5% 5/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	3.5% 5/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	3.5% 5/141 • Number of events 5 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Dysphagia	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Gastrointestinal inflammation	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Hiatus hernia	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Gastrointestinal disorders Nausea	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Adverse drug reaction	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Catheter site haematoma	9.2% 13/141 • Number of events 13 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	9.2% 13/141 • Number of events 13 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	9.2% 13/141 • Number of events 13 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Catheter site haemorrhage	6.4% 9/141 • Number of events 9 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	6.4% 9/141 • Number of events 9 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	6.4% 9/141 • Number of events 9 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Catheter site pain	4.3% 6/141 • Number of events 6 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	4.3% 6/141 • Number of events 6 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	4.3% 6/141 • Number of events 6 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Fatigue	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
General disorders Local swelling	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Infections and infestations Catheter site infection	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Concussion	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Fall	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Head injury	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Periorbital Haemorrhage	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Metabolism and nutrition disorders Hypervolaemia	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Metabolism and nutrition disorders Hypovolaemia	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Muscular weakness	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Neck pain	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Pain in extremity	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Aphasia	2.1% 3/141 • Number of events 3 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.8% 4/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	2.8% 4/141 • Number of events 4 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)
Nervous system disorders Ataxia	0.00% 0/141 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)	0.71% 1/141 • Number of events 1 • Adverse Events were collected from the point of consent through year 3 The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * All Adverse Events (AE) with an underlying neurological cause (Neurological Adverse Events) * All Device Related Adverse Events * All Procedure Related Adverse Events * All Serious Adverse Events (SAE's)