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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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Application Number P060038 S017/ PAS001
Current Plan Approved 11/25/2014
Study Name OSB Lead-NEMO PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a prospective, non-randomized, multicenter post-

approval study (PAS)

Primary effectiveness:

*To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature; and

*To evaluate the overall improvements in patient condition by comparison of pre- operative and post-operative New York Heart Association (NYHA) functional classification.

Secondary safety objective:

*To determine early (day 1-30) and late (>30 days) valve-related adverse event rates (including valve thrombosis, thromboembolism, paravalvular leak (all and major), bleeding (all and major) and endocarditis for Mitroflow DL are comparable to appropriate historical controls manifested as Objective Performance Criteria (OPC) in the FDA¿s Heart Valve Guidance4 and the ISO 5840 guidelines.

* Additional safety endpoints to be included are rates of the

following adverse events: hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant, and death (all- cause and valve-related).

Study Population Description Patients who were implanted with Mitroflow, Model DL,

implantation according to the Instructions for Use (IFU).

Historical controls specified as objective performance criteria (OPCs) in the FDA Draft Replacement Heart Valve Guidance (where applicable).

Sample Size Assuming a 32% mortality and 20% attrition rate into account, the PAS will include a minimum of 15 U.S. sites and 185 patients implanted with the Mitroflow DL valve in a commercial environment. A minimum of one-hundred (100) patients followed for at least eight (8) years will be necessary to comply with the

800 patient/year requirement outlined in the FDA Heart Valve


Data Collection Occurrence of early and late structural valve deterioration (SVD) and valve-related complications (early and late), including valve thrombosis, thromboembolism, bleeding, anticoagulation-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, non-structural dysfunction, reoperation, explant and death.

The primary hemodynamic effectiveness endpoints for hemodynamic performance of the valve to be evaluated are

trans-valvular peak and mean pressure gradients, effective orifice area (EOA) and EOA index (EOAI), performance index (PI), cardiac output (CO), cardiac index (CI), the location and severity of regurgitation, and LV mass regression.

Follow-up Visits and Length of Follow-up 8 years



¿Post-operative (within 30 days of implant)

¿Annual clinical and echocardiographic follow-up

OSB Lead-NEMO PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/17/2014 10/15/2014 On Time
one year report 04/18/2015 04/17/2015 On Time
18 month report 10/17/2015 10/16/2015 On Time
two year report 04/17/2016 04/15/2016 On Time
three year report 04/17/2017    
four year report 04/17/2018    
five year report 04/17/2019    

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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