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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 - ACUITY Long-Term Registry


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General
Application Number P010012 S160/ PAS001
Current Plan Approved 06/25/2009
Study Name OSB Lead - ACUITY Long-Term Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description prospective, non-randomized, multi-center registry
Study Population Description The study population will consist of patients who: were successfully implanted with the ACUITY Spiral Lead, meet the study criteria.
Sample Size 1,700 patients, 150 sites
Data Collection Chronic LV lead-related complication-free rate over a five year follow- up period
Follow-up Visits and Length of Follow-up Patients will be followed until they have completed five years of

follow-up from implant or until death, withdrawal, or closure of the registry.

Patients will have an in-clinic follow-up visit one month (15 to 29

days) post implant and then subsequently be followed according to the center¿s standard follow-up schedule, with complete in-clinic system interrogation recommended to be at least once every six months.

Final Study Results
Interim Safety Information This study has enrolled 258 patients. There are very few patients with volatage threshold out of performance standards bounds (ranging from 96-100% from enrollment to the third quarter). There are no issues with pacing impedance which remained in bounds (between 200 and 2000 Ohms) for 100% of the patients in each quarter post-implant. The energy output was <0.5 from enrollment to the third quarter. Sensing Amplitude (>3 mV) does not raise concern as it ranged from 98-100% from enrollment to the third quarter. There have been 7 deaths and 17 leads reported as out of service. There have been 37 adverse events in 34 patients. These specific events do not indicate any safety concern thus far.


OSB Lead - ACUITY Long-Term Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
18 month report 11/14/2009 11/13/2009 On Time
2 year report 05/16/2010 05/14/2010 On Time
30 month report 11/14/2010 11/15/2010 Overdue/Received
3 year report 05/16/2011 05/12/2011 On Time
42 month report 11/14/2011 11/14/2011 On Time
4 year report 05/15/2012 05/15/2012 On Time
54 month report 11/13/2012 11/13/2012 On Time
5 year report 05/15/2013 05/13/2013 On Time
interim report 11/13/2013 11/07/2013 On Time
6 year report 05/15/2014 05/05/2014 On Time
78 month report 11/15/2014 11/13/2014 On Time
7 year report 05/15/2015 05/12/2015 On Time
interim report 11/15/2015 11/04/2015 On Time
8 year report 07/14/2016 06/27/2016 On Time
102 month report 11/14/2016    
9 year report 05/14/2017    


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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