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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Extended F/u 25cm Viabahn Endoprosthesis


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General
Application Number P040037 S050/ PAS001
Current Plan Approved 10/18/2013
Study Name OSB Lead-Extended F/u 25cm Viabahn Endoprosthesis
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Final Study Results
Number of Patients 71 (58 subjects available at 1 year).
Number of Sites 6
Follow-up Rate at 3 years (51 eligible subjects) – 90.2% (46/51)
Safety Findings Total number of device- or procedure-related adverse reported = 62

Most common organ class was general disorders and administration site conditions- 46 events

Proportion of subjects with device- or procedure-related adverse events, overall - 50.7% (36/71)







Total number of device- or procedure-related serious adverse events reported = 40

Most common organ class was general disorders and administration site conditions- 31 events

Proportion of subjects with device- or procedure-related serious adverse events, overall – 35.2% (25/71)

Effect Findings Primary Endpoint



The primary patency rate at 36 months by Kaplan Meier (KM) estimate was 40.6% Secondary Endpoints (by Kaplan Meier Analysis)

Primary Assisted Patency rate at 24 and 36 months was 65.3% and 53.0% respectively



Secondary patency rate at 24 and 36 months was 96.9% at each timepoint



Freedom from target lesion revascularizations at 24 and 36 months was 65.1% and 55.5% respectively



Freedom from the composite of death, target vessel revascularization and amputation at 24 and 36 months was 56.5% and 44.5% respectively



The clinical Success rate at 24 and 36 months was 76.7% and 58.5% respectively. There were no reports of device fracture on X-ray

Strengths & Weaknesses The study achieved an adequate follow-up rate of 90.2% at 3 years.



Weaknesses

This was a single arm study without a comparator. Thus, the study result was not evaluated by a formal statistical test.

Label Changes Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.


OSB Lead-Extended F/u 25cm Viabahn Endoprosthesis Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/18/2014 12/12/2013 On Time
one year report 12/18/2014 12/15/2014 On Time
Final report 12/18/2015 12/17/2015 On Time


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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