Trial Outcomes & Findings for Medtronic Signia SDR Product Surveillance Registry (NCT NCT05095935)

Last Updated: 2026-01-07

Results Overview

* Adult Thoracic: incidence of intraoperative hemostatic intervention related to the transection of pulmonary arteries and veins. * Adult Abdominal: incidence of intraoperative hemostatic intervention related to the transection of renal arteries and veins. * Pediatric Abdominal: incidence of intraoperative hemostatic and leak intervention related to the transection of the appendiceal stump and mesoappendix (simple acute appendicitis).

Recruitment status

COMPLETED

Target enrollment

430 participants

Primary outcome timeframe

During Procedure

Results posted on

2026-01-07

Participant Flow

Patients undergoing surgical procedures during which the Signia Small Diameter Reload is being used for the transection of vasculature or thin tissue meeting the cohort criteria were considered for this study.

This study was conducted in accordance with each site's standard of care. Assignment to one of the three study groups was dependent on the anatomical location where Signia SDR was used and was not randomly assigned.

Participant milestones

Participant milestones
Measure	Thoracic Adult Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Overall Study STARTED	123	163	95
Overall Study COMPLETED	123	163	95
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medtronic Signia SDR Product Surveillance Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thoracic Adult n=123 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=163 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 Participants Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.	Total n=381 Participants Total of all reporting groups
Age, Continuous	66.2 Years STANDARD_DEVIATION 12.1 • n=37 Participants	48.4 Years STANDARD_DEVIATION 13.5 • n=56 Participants	11.3 Years STANDARD_DEVIATION 3.8 • n=95 Participants	44.9 Years STANDARD_DEVIATION 23.7 • n=61 Participants
Sex: Female, Male Female	66 Participants n=37 Participants	95 Participants n=56 Participants	31 Participants n=95 Participants	192 Participants n=61 Participants
Sex: Female, Male Male	57 Participants n=37 Participants	68 Participants n=56 Participants	64 Participants n=95 Participants	189 Participants n=61 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=37 Participants	20 Participants n=56 Participants	42 Participants n=95 Participants	67 Participants n=61 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=37 Participants	130 Participants n=56 Participants	53 Participants n=95 Participants	292 Participants n=61 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=37 Participants	13 Participants n=56 Participants	0 Participants n=95 Participants	22 Participants n=61 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants	0 Participants n=56 Participants	2 Participants n=95 Participants	3 Participants n=61 Participants
Race (NIH/OMB) Asian	3 Participants n=37 Participants	5 Participants n=56 Participants	1 Participants n=95 Participants	9 Participants n=61 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=56 Participants	0 Participants n=95 Participants	0 Participants n=61 Participants
Race (NIH/OMB) Black or African American	6 Participants n=37 Participants	28 Participants n=56 Participants	10 Participants n=95 Participants	44 Participants n=61 Participants
Race (NIH/OMB) White	107 Participants n=37 Participants	100 Participants n=56 Participants	49 Participants n=95 Participants	256 Participants n=61 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	3 Participants n=56 Participants	0 Participants n=95 Participants	3 Participants n=61 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=37 Participants	27 Participants n=56 Participants	33 Participants n=95 Participants	66 Participants n=61 Participants
Region of Enrollment United States	123 Participants n=37 Participants	163 Participants n=56 Participants	95 Participants n=95 Participants	381 Participants n=61 Participants

PRIMARY outcome

Timeframe: During Procedure

Population: Analysis was conducted on the number of firings of the Signia SDR device. Study participants could have 1 or more firings.

Outcome measures

Outcome measures
Measure	Thoracic Adult n=123 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=163 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=100 Firings Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Incidence of Intraoperative Hemostatic Intervention	3 Firings	2 Firings	0 Firings

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Thoracic Adult n=120 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=157 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 Participants Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During Procedure

The Likert Scale assessment is a bleeding assessment that was conducted during the procedure, ranging from 1 (no bleeding) to 5 (significant bleeding requiring intervention). Staple line integrity was considered achieved for firings with a Likert Scale Score of 1, 2, 3 and 777 (not recorded at time of procedure, but deemed acceptable by the procedure surgeon).

Outcome measures

Outcome measures
Measure	Thoracic Adult n=120 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=157 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 Participants Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Intraoperative Assessments: Assessment of Staple Line Integrity Using a Five-point Likert Scale	117 Participants	156 Participants	95 Participants

SECONDARY outcome

Timeframe: During Procedure

Number of firings that had an incidence of staple line bleeding of \>50cc

Outcome measures

Outcome measures
Measure	Thoracic Adult n=302 Firings Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=327 Firings Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=100 Firings Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Intraoperative Assessments: Incidence of Staple Line Bleeding	0 Firings	0 Firings	0 Firings

SECONDARY outcome

Timeframe: During Procedure

Additional interoperative interventions to treat staple line failure (applying additional stapler reloads, applying compression greater than what is considered typical, over-sewing with suture, placing clips, use of energy, use of seatbelt, other)

Outcome measures

Outcome measures
Measure	Thoracic Adult n=120 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=157 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 Participants Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Intraoperative Assessments: Additional Intervention(s) to Treat Staple Line Failure	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Additional postoperative interventions to treat staple line failure (Applying additional stapler reloads, Applying compression greater than what is considered typical, Over-sewing with suture, Placing clips, Use of energy, Use of seatbelt, Other)

Outcome measures

Outcome measures
Measure	Thoracic Adult n=120 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=157 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 Participants Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Post-operative Assessments: Additional Intervention(s) to Treat Staple-line Failure	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30-days

incidence of subjects reporting device deficiencies affecting the intended performance of the device up to and including 30 days following the use of device (i.e. Signia™ Small Diameter Reloads) in surgery

Outcome measures

Outcome measures
Measure	Thoracic Adult n=123 Participants Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=163 Participants Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 Participants Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Device Deficiencies	0 Participants	1 Participants	0 Participants

Adverse Events

Thoracic Adult

Serious events: 43 serious events

Other events: 6 other events

Deaths: 0 deaths

Abdominal Adult

Serious events: 7 serious events

Other events: 6 other events

Deaths: 0 deaths

Abdominal Pediatric

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jennifer Bell

Medtronic

Phone: 303-241-2107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PIs may publish as long as publications are provided to Medtronic for review at least 30 days prior to submission or presentation. Additionally, PIs will not independently publish, publicly disclose, present or discuss any Study results until a multi-center publication is released. If a multi-center publication is not released within one year after completion PIs will have the right to publish the results of and information pertaining to their activities on the Study.
Publication restrictions are in place

Restriction type: OTHER

Measure	Thoracic Adult n=123 participants at risk Use of Signia SDR for the transection of pulmonary arteries and veins in adult patients.	Abdominal Adult n=163 participants at risk Use of Signia SDR for the transection of renal arteries and veins in adult patients.	Abdominal Pediatric n=95 participants at risk Use of Signia SDR for the transection of the appendiceal stump and mesoappendix (simple acute appendicitis) in pediatric patients.
Gastrointestinal disorders Constipation	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Blood and lymphatic system disorders Lymphadenopathy	0.81% 1/123 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Cardiac disorders Tachycardia	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Gastrointestinal disorders Abdominal Pain	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Gastrointestinal disorders Dysphagia	1.6% 2/123 • Number of events 2 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Gastrointestinal disorders Nausea	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Gastrointestinal disorders Vomiting	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	2.1% 2/95 • Number of events 2 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
General disorders Adverse Drug Reaction	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
General disorders Pyrexia	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Immune system disorders Allergy To Surgical Sutures	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Infections and infestations Bacteraemia	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Infections and infestations Clostridium Difficile Infection	0.81% 1/123 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Infections and infestations Urinary Tract Infection	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Injury, poisoning and procedural complications Incision Site Discharge	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Injury, poisoning and procedural complications Post Procedural Constipation	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	1.1% 1/95 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Injury, poisoning and procedural complications Procedural Pain	0.81% 1/123 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Product Issues Device Leakage	1.6% 2/123 • Number of events 2 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Renal and urinary disorders Acute Kidney Injury	0.81% 1/123 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Renal and urinary disorders Haematuria	0.00% 0/123 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.61% 1/163 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.
Vascular disorders Arterial Haemorrhage	0.81% 1/123 • Number of events 1 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/163 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.	0.00% 0/95 • from enrollment until end of 30 day follow-up Procedure and/or device related AEs were reportable in this study. Subject follow-up period was 30-days post procedure; no events were collected beyond 30-days post procedure.