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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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Study Status Completed
Application Number P100028 / PAS001
Date Current Protocol Accepted 12/05/2011
Study Name REFORM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Interim or Final Data Summary
Actual Number of Patients Enrolled 100
Actual Number of Sites Enrolled 7
Patient Follow-up Rate 95%
Final Safety Findings No significant safety problems were reported at 36 months. A clinically significant decrease in systolic blood pressure was sustained for 36 months.
Final Effect Findings The rate of the primary endpoint was 91.7% and the lower limit of the 95% two-sided confidence interval was 84.2%. The primary premarket hypothesis tested was the 9-month primary patency rate that resulted greater than 60% (p < 0.001). Therefore, the rate was higher than the performance goal. Technical Success was 97.4% (112/115) on a per lesion basis.
Study Strengths & Weaknesses Results provide further evidence of the clinical utility and safety of this device.

Recommendations for Labeling Changes Post-approval study findings should be part of the device labeling, including the following key safety findings: the 9-month primary patency rate (table 3.10-1), Major Adverse Events (table 3.11.1-1), technical success, acute procedural success (tables 3.11.2-1 and3.11.3-1), blood pressure results (table3.11.6.1-1) cured and improved hypertension at 36 months (table

1) and renal function results (tables 3.11.7-1 and 3.11.7-2).

REFORM Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 07/15/2011 07/13/2011 On Time
one year report 01/14/2012 01/13/2012 On Time
18 month report 07/14/2012 07/06/2012 On Time
two year report-FINAL 01/25/2013 01/22/2013 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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