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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Heart Laser CO2


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General
Study Status Completed
Application Number /
Requirement Number		 P950015 / PAS001
Date Original Protocol Accepted 08/20/1998
Date Current Protocol Accepted  
Study Name Heart Laser CO2
Device Name THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a two-armed prospective cohort, multi-stite registry study. The registry was randomly divided between those who received TMR at the time of enrollment and those whose TMR was delayed for 30 days.
Study Population The study population was patients for whom the Chilli device is indicated, who had failed or were intolerant to drug therapy. The device is approved for the treatment of refractory class 3-4 angina secondary to objectively demonstrated coronary artery atherosclerosis not amenable to standard therapies such as CABG or PTCA.
Sample Size 600 patients. 39 sites. Patients to be randomly divided between those who received TMR at the time of enrollment and those who were delayed 30 days prior to treatment.
Key Study Endpoints The primary endpoint was 30-day and one-year mortality. The secondary endpoint was adverse events.
Follow-up Visits and Length of Follow-up The primary endpoints were evaluated at 30 days and one year.
Interim or Final Data Summary
Interim Results Study completed, see final results.
Actual Number of Patients Enrolled 516 patients
Actual Number of Sites Enrolled 39 sites
Patient Follow-up Rate 92%
Final Safety Findings There was a high one month mortality rate were compared to the pre-market study.
Study Strengths & Weaknesses Weaknesses: The data that was internally inconsistent and there was no comparison of the primary endpoint with a meaningful control group.
Recommendations for Labeling Changes None


Heart Laser CO2 Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final PAS Report 02/28/2007 02/28/2007 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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