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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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Registry AMS MC-0611

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Study Status Completed
Application Number P000053 S005/ PAS001
Date Current Protocol Accepted 02/07/2007
Study Name Registry AMS MC-0611
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent & Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The sponsor has created a registry-based study that will include all patients who have received an AUS 800 or AUS 800 with IZ at a US-based site subsequent to October 13, 2006. It is a passive surveillance system where information is voluntarily submitted to AMS by the implanting physician and is tied to credit for new devices under warranty.

The purpose of the registry is to evaluate the long-term performance of the AUS 800 compared to the AUS 800 with IZ by evaluating infection, mechanical component and system failures and surgical revision. The study hypothesis is that there is equal survival time (based on device replacement due to infection or mechanical failure) for IZ impregnated versus unimpregnated devices.The objective of this post-approval registry is to evaluate the long term performance of the AMS 800 against the long term performance of the AMS 800 with InhibiZone as it relates to rate of infection, mechanical component or system failures and surgical revision rates.
Study Population Description Study population is as per device indication. This device is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.
Sample Size All comers registry
Data Collection Primary endpoint is device replacement surgery
Follow-up Visits and Length of Follow-up There are no follow up visits in this study; the entire study will include 5 years of follow up for each patient.
Interim or Final Data Summary
Interim Safety Information 6.8% of device implantations required revision compared to 12.4% of non-IZ devices. There is no statistically significant difference in any of the outcome rates, with the exception of revisions due to mechanical malfunction in the original surgery group. This rate, while statistically different, was a small rate of revisions (<2.0%). There are no safety concerns noted from this report. Additional surveillance of safety is ongoing in annual reports.
Actual Number of Patients Enrolled 17,063 subjects
Actual Number of Sites Enrolled 2,240 sites
Patient Follow-up Rate

There was no formal follow쳌]up in this registry쳌]based study. The post쳌]approval study included patients who were implanted with the AMS 800 device between October 14, 2006 and July 31, 2012 and those receiving revisions on a previously implanted AMS 800 device through July 31, 2012.

Final Safety Findings Infection Free Rates

For the overall system, the infection free rates were not significantly different between the

Inhibizone (IZ) and non쳌]Inhibizone (non쳌]IZ) groups in the Original surgery group (98.26% vs.

98.22%) and in the Revision surgery group (96.77% vs. 96.48%). For specific components, there were also no statistically significant differences in infection free rates between the IZ and non쳌]IZ devices in both Original and Revision surgery groups.

Mechanical Malfunction Free Rates

For the overall system, in the Original Surgery Group, the IZ group had a significantly lower malfunction free rate than the non쳌]IZ group (93.47% vs. 95.22%, P=0.003). However, in the Revision Surgery Group, the malfunction free rate was not significantly different between the IZ and non쳌]IZ groups (92.85% vs. 92.81%, P>0.05).

For the Components analysis, in the Original Surgery Group, the difference in malfunction free rates for the Pump and Balloon were not statistically significant, but the differences in malfunction free rates for the cuff [IZ 98.40% vs. non쳌]IZ 99.04%, P=0.007] and the Not Specified Component [IZ 97.11% vs. non쳌]IZ 98.16%, P=0.03] were statistically significant. In the Revision Surgery Group components analysis, there were no statistically significant differences in malfunction free rates.

Final Effect Findings For both the Original Surgery Group and the Revision Surgery Group, the 5쳌]year revision free rate from any cause was higher in the IZ group compared to the non쳌]IZ group but the difference was not statistically significant [Original Surgery Group: (IZ 78.94% vs. non쳌]IZ 77.79%; difference=1.15%; log rank test P= 0.191); Revision Surgery Group: (IZ 73.85% vs. non쳌]IZ 72.04%; difference=1.81%; log rank test P=


Study Strengths & Weaknesses Strengths

An all쳌]comers Registry쳌]based study with large, representative study sample


There is no formal follow쳌]up plan, which may contribute to bias and underreporting of events. In addition, the database does not record events (e.g., infection) that are successfully treated without a surgical explant procedure, i.e., if no implanted system component change occurs or no surgical device adjustment occurs, the study did not record the (infection) event in the database. Therefore, the reported adverse event rates may be lower than the actual rate experienced by participating patients.
Recommendations for Labeling Changes Labeling change recommended to include long쳌]term safety and effectiveness data from the registry쳌]based study.

Registry AMS MC-0611 Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 10/13/2007 10/15/2007 Overdue/Received
2 year report 10/12/2008 10/10/2008 On Time
3 year report 10/12/2009 10/13/2009 Overdue/Received
48 month interim report 10/12/2010 10/12/2010 On Time
5 year report 10/12/2011 10/12/2011 On Time
6 year report - final report 01/12/2013 01/14/2013 Overdue/Received

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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