Trial Outcomes & Findings for Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study (NCT NCT01608490)

Last Updated: 2021-07-19

Results Overview

mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed)

Recruitment status

TERMINATED

Study phase

Target enrollment

315 participants

Primary outcome timeframe

baseline through 12 months follow up

Results posted on

2021-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	RePneu Lung Volume Reduction Coil System The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Overall Study STARTED	158	157
Overall Study COMPLETED	141	142
Overall Study NOT COMPLETED	17	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.	Total n=315 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 8.05 • n=5 Participants	64.3 years STANDARD_DEVIATION 7.76 • n=7 Participants	63.9 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	86 Participants n=5 Participants	79 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	78 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	157 Participants n=5 Participants	155 Participants n=7 Participants	312 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline through 12 months follow up

Population: Patients who were analyzed at 12 months.

mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed)

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up	10.3 meters Interval -33.0 to 45.0	-7.6 meters Interval -40.0 to 26.0

SECONDARY outcome

Timeframe: BL to 12 months

Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Mean Percent Change in FEV1 From Baseline to 12 Months	3.8 percentage change Interval -6.3 to 16.1	-2.5 percentage change Interval -8.9 to 4.4

SECONDARY outcome

Timeframe: BL to 12 months

mean absolute difference in SGRQ results comparing BL to 12 months, LVRC vs. Control, score is on a scale from 0 to 100, negative change will be a better outcome.

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months	-8.1 score on a scale Standard Error 1.08	0.8 score on a scale Standard Error 1.05

SECONDARY outcome

Timeframe: 12 months

6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
6MWT Responder Analysis	60 Participants	41 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
SGRQ Responder Analysis	98 Participants	48 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Mean absolute difference in RV results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months	-0.41 liters Standard Error 0.081	-0.10 liters Standard Error 0.080

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Mean absolute difference in RV/TLC (residual volume/total lung capacity - a measure done during lung function testing where residual volume is air left over in lung after completely breathing out and total lung capacity is how much air the lung can breathe in) results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control

Outcome measures

Outcome measures
Measure	RePneu Lung Volume Reduction Coil System n=158 Participants The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 Participants The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
RV/TLC Mean Absolute Difference From Baseline to 12 Months	-3.96 percent Standard Error 0.564	-0.45 percent Standard Error 0.554

Adverse Events

RePneu Lung Volume Reduction Coil System

Serious events: 78 serious events

Other events: 155 other events

Deaths: 10 deaths

Control Arm is Standard Medical Care

Serious events: 44 serious events

Other events: 142 other events

Deaths: 8 deaths

Serious adverse events

Other adverse events

Additional Information

Kristi Winterfeldt

Boston Scientific

Phone: +1 763-494-1165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	RePneu Lung Volume Reduction Coil System n=155 participants at risk The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 participants at risk The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Gastrointestinal disorders Intestinal obstruction	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Acute myocardial infarction	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Angina pectoris	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Atrial fibrillation	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Cardiac failure	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Cardiomyopathy	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Sinus tachycardia	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Supraventricular tachycardia	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Tachycardia	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Abdominal pain	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Colitis	0.65% 1/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Diverticulum	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Food poisoning	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Pneumoperitoneum	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Small intestinal obstruction	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
General disorders Adverse drug reaction	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
General disorders Asthenia	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
General disorders Chest pain	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
General disorders Medical device complication	3.2% 5/155 • Number of events 5 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Hepatobiliary disorders Cholecystitis	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Immune system disorders Allergy to metals	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Immune system disorders Latex allergy	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Abdominal sepsis	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Bronchitis	3.2% 5/155 • Number of events 5 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.3% 2/157 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Bronchitis bacterial	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Bronchopulmonary aspergillosis	1.9% 3/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Diverticulitis	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Gastrointestinal infection	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Influenza	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Lung infection	1.3% 2/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Lung infection pseudomonal	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Pneumonia	20.0% 31/155 • Number of events 34 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	5.1% 8/157 • Number of events 10 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Pneumonia staphylococcal	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Pseudomonas infection	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Sepsis	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Septic shock	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Subacute endocarditis	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Infections and infestations Tracheobronchitis	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.

Other adverse events
Measure	RePneu Lung Volume Reduction Coil System n=155 participants at risk The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	Control Arm is Standard Medical Care n=157 participants at risk The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
Infections and infestations Pseudomonas infection	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Blood and lymphatic system disorders Anaemia	1.9% 3/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Acute myocardial infarction	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Angina pectoris	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Atrial fibrillation	1.9% 3/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.3% 2/157 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Cardiac failure	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Cardiomyopathy	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Left ventricular failure	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Palpitations	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Sinus tachycardia	1.9% 3/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Supraventricular extrasystoles	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Tachyarrhthmia	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Cardiac disorders Tachycardia	1.9% 3/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	2.5% 4/157 • Number of events 5 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Congenital, familial and genetic disorders Hydrocele	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Ear and labyrinth disorders Ear pain	0.65% 1/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Ear and labyrinth disorders Vertigo	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Endocrine disorders Hypothyroidism	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.9% 3/157 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Eye disorders Cataract	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.9% 3/157 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Eye disorders Conjunctival haemorrhage	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Eye disorders Conjunctivitis	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.3% 2/157 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Eye disorders Eye haemorrhage	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Eye disorders Glaucoma	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Abdominal distension	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Abdominal pain	3.9% 6/155 • Number of events 6 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Abdominal pain lower	1.3% 2/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Colitis	0.65% 1/155 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Constipation	1.3% 2/155 • Number of events 3 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Dental caries	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Diarrhoea	2.6% 4/155 • Number of events 4 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.3% 2/157 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Diverticulum	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Dry mouth	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Dyspepsia	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Dysphagia	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	1.3% 2/157 • Number of events 2 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Food poisoning	0.00% 0/155 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Gastroesophageal reflux disease	3.2% 5/155 • Number of events 5 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Intestinal obstruction	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Nausea	2.6% 4/155 • Number of events 4 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.64% 1/157 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Pneumoperitoneum	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.
Gastrointestinal disorders Rectal haemorrhage	0.65% 1/155 • Number of events 1 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.	0.00% 0/157 • 12 months Complications occurring in the treatment arm were further categorized as device-related, procedure-related, or neither, and by those occurring during procedure hospitalization and those occurring post-discharge. Adverse events for the treatment group are only reported for subjects who began the treatment. Three (3) subjects discontinued the study prior to treatment, and are therefore not part of the safety population.