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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ODE Lead-INGEVITY and SAMURAI


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General
Study Status Progress Adequate
Application Number P150012 / PAS001
Study Name ODE Lead-INGEVITY and SAMURAI
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Two studies (INGEVITY and SAMURAI) have been conducted by Boston Scientific to fulfill the pre-market requirement of the INGEVITY family of leads and ImageReady MRI Conditional Pacing System (IPGs). All study visits through 12 months have already been completed for the pre-market study report. Patients in both studies will be continually followed for 60 months to fulfill the post-market requirements.

INGEVITY Study

The INGEVITY Lead Clinical Study was a prospective, multi-center, global, nonrandomized clinical study conducted to establish the safety, performance and effectiveness of theINGEVITY non-MRI Active and Passive Fixation Pace/ Sense Leads. A total of 1599 leads implanted in 1036 patients that were used for premarket endpoint analyses will be continually followed to achieve the minimum number of leads evaluable at 60 months. All patients have been consented for five years. Study procedures or clinic visits will occur every six (6) months following implant through the final 60 month visit.

SAMURAI Study

The SAMURAI Clinical Study was a prospective, multi-center, global, open-label, two-group (MRI arm and Control arm) randomized clinical study conducted to establish the safety, performance and effectiveness of the ImageReady MRI Conditional Pacing System when used in the MRI environment under the labeled Conditions of Use. A total of 351 patients from both arms implanted with an ImageReady system that were used for premarket endpoint analyses will be continually followed to achieve the minimum number of IPS system evaluable at 60 months. All patients have been consented for five years.
Study Population Description Subjects who were enrolled in INGEVITY study and SAMURAI study will be continually followed to achieve the proposed minimum number of leads/IPGs at 60 months. All patients have been consented for five years. There is no new enrollment proposed.
Sample Size Between the INGEVITY and SAMURAI studies, Boston Scientific has implanted or attempted 2264 INGEVITY leads across 118 sites with over 50% of the leads from the US. Each of these 2264 leads will be followed for five years, minus attrition due to patient death and withdrawal and leads taken out of service. Based on an annual attrition rate of 6.3% (observed through early 2015), the 5 year attrition rate is expected to be 27.8%. This estimated 5 year attrition rate was then used to project that approximately 1634 INGEVITY leads will complete 5 years of follow-up.

A minimum sample size of 245 leads is required to evaluate the INGEVITY Lead Post-Approval Safety Endpoint. This sample size was calculated via Monte Carlo simulations

employing Kaplan-Meier methodology, using SAS version 9.3 with the following assumptions:

Expected performance = 97.5%

Performance goal = 92.5%

Expected attrition/missing data = 27.8% (based on 6.3% annual attrition observed in the INGEVITY and SAMURAI studies)

One-sided significance level = 5%

Power = 95%

A sample size of 171 MR Scans is required to evaluate the ImageReady MR Conditional Pacing System Safety Endpoint. This sample size was calculated using the normal approximation to the binomial and confirmed via Monte Carlo simulations employing Kaplan-Meier methodology, using SAS version 9.3 with the following assumptions:

? Performance goal = 95%

? Expected MR Scan-related CFR rate between MR Scan and 1 month post-scan =99%

? One-sided significance level = 5%

? Power = 95%

To fulfill FDA post-approval requirements, there will be 75 patients with multiple MRI scans during the course of the five year follow-up.
Data Collection Primary Outcome Measures:

INGEVITY Lead Post-Approval Safety Endpoint: Lead-related Complication-Free Rate from 1 to 60 Months

ImageReady MRI Conditional Pacing System Post-Approval Safety Endpoint: MR Scan-Related Complication-Free Rate between MR Scan and 1 Month following MR Scan

Additional data includes, but is not limited to, adverse events, deaths, device deficiencies, protocol deviations, lead measurements and study visit compliance. Impacts of Multiple MRI Scans on MRI Scan-related Complications and Pacing Thresholds and Sensed Amplitudes.
Follow-up Visits and Length of Follow-up 60 months


ODE Lead-INGEVITY and SAMURAI Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/31/2016 08/01/2016 Overdue/Received
one year report 01/31/2017 01/31/2017 On Time
18 month report 07/31/2017 08/03/2017 Overdue/Received
two year report 01/31/2018    
three year report 01/31/2019    
four year report/final report 01/31/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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