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and/or updated patient information is received by AMS. The PIF
information fields used in this analysis included:
• Concomitant conditions and etiologies including both
neurogenic and non-neurogenic origins.
• Device information, such as model, part number and serial
number,
• Revision surgeries and the reason for revision, and
• Demographic and surgical variables, such as age and surgical
approach used.
Key Registry Endpoints
This study compared the rates of device replacement surgery
subsequent to infection or mechanical failure between IZ and
Non-IZ AMS 800 devices.
At the study’s conclusion survival from infection and mechanical
failure of the IZ and Non-IZ device groups were compared by
standard survival analysis. The comparison was performed by
using a survival analysis separately on infection and mechanical
failure events.
Total Number of Enrolled Registry Sites and Subjects, Follow-up
Rate
• 24,257 AMS 800 patient implants total
• 17,063 Original Surgery Group patients
• 7,194 Revision Surgery Group patients
• 3,548 physicians total
• 2,240 sites total, with all 50 States and several U.S. territories
represented
The study was based on the voluntary submission of AMS
implant registration data using the AMS PIF. While there was a
relatively high PIF return rate, there was not 100% compliance.
Study Visits and Length of Follow-up
As the study utilizes a voluntary implant registration data form
to report events (i.e., PIF for Original Surgery Group and the
Revision Surgery Group), there were no specified “study visit”
intervals. Overall endpoints were analyzed to 2117 days, i.e., 5.8
years post-procedure.
Summary of the Prospective Post-market Registry Study Results
The study evaluated the antimicrobial effectiveness and safe
use over a five (5) year period, including the rate of infection,
mechanical component, or system failures and surgical revision
rates.
Final Safety Findings
The final safety findings are described in Table 4 and the
associated text below.
Table 4: Original Surgery Group and the Revision Surgery
Group Analyzed for Overall Revision, Infection (only)
Revision, and Mechanical Malfunction (only) Revision
Original Surgery
Group
Revision Surgery
Group
OVERALL REVISION
Total Implant Surgeries
17,063
7,194
• IZ devices
13,060 (76.5%)
4,352 (60.5%)
• Non-IZ devices
3,742 (21.9%)
1,891 (26.3%)
• Mixed
(IZ & Non-IZ*)
261 (1.5%)
951 (13.2%)
Revision Free Patients
14,410 (85.8%)
4,969 (79.6%)
Revision Events
2,392 (14.2%)
1,274 (20.4%)
• IZ devices
[% revision free]
1,621 (12.4%)
[87. 6%]
776 (17.8%)
[82.2%]
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