Boston Scientific AMS 700 Mode D'emploi page 9

closed. When multiple reasons were listed for 1 revision surgery (e.g., infection, device
malfunction, erosion, etc.), the individual revision surgery was counted and included
in the data for each of the indicated revision reasons. Thus, all revisions that report
some presence of infection will be captured in the infection category presented in this
analysis (even if multiple other reasons for the revision surgery are listed).
Life tables were constructed and the log rank test was used to compare the
device survival distributions between the Treatment (InhibiZone™) and Control
(non-InhibiZone) groups. All significance tests were performed at an alpha level of 0.05.
For original implants, device survival distributions were defined as the time between
the implantation of the original device in the analysis period and the first replacement,
revision, or removal of any component of the device due to infection, malfunction, fluid
loss, erosion, patient dissatisfaction, or other reason (the Original Implant Group).
For revision surgery patients, device survival distributions were created for the time
between the implantation of the revision device and the next revision device due to
infection, malfunction, fluid loss, erosion, patient dissatisfaction, or other reason (the
Revision Surgery Group). The study also included a subgroup of patients who received
a penile implant after spinal cord injury. However, this aspect of the analysis continues
to be unknown, since there were too few patients in this group to be able to determine
valid conclusions.
Original Implant Patient Group
Among the original implant patients, a total of 31,328 (98.7%) patient devices did not
have any events reported due to infection and were censored during the timeframe of
this report. A total of 338 (1.2%) device events were due to infection in the InhibiZone
treated group while 84 (2.5%) were due to infection in the non-InhibiZone treated group.
Life table analyses compared the rates of revision surgery due to infection for original
InhibiZone or non-InhibiZone treated implants. In this device survival analysis with
infection as the reason for the revision surgery, InhibiZone treated AMS 700™ Devices
had a significantly better survival than non-InhibiZone treated devices among original
implant patients (p<0.0001) (Figure 8).
Figure 8: Device survival—freedom from revision due to infection among original
implant patients
Diabetic Original Implant Patient Group
Among the subgroup of original implant patients who had diabetes, a total of 5604
diabetic patients included 4977 (88.8%) with InhibiZone treated devices and 627 (11.2%)
with non-InhibiZone treated devices. A total of 5508 (98.3%) diabetic patient devices
did not have any events due to infection during the timeframe of this report. Only 71
(1.4%) infection device events were in the InhibiZone treated group while 25 (4.0%)
events were in the non-InhibiZone treated group. Life table analyses compared rates
of revision surgery due to infection for diabetic patients. InhibiZone treated devices
had significantly better survivals than non-InhibiZone treated devices among diabetic
patients (p<0.0001) (Figure 9).
Figure 9: Device survival—freedom from revision due to infection among diabetic
patients
Revision Surgery Implant Group
Among the revision surgery implant patients, a total of 10,769 (97.3%) patient devices
did not have any events due to infection and were censored during the timeframe of
this report. Only 229 (2.5%) infection device events occurred in the InhibiZone treated
group while 66 (3.7%) infection events occurred in the non-InhibiZone treated group.
Life table analysis compared the rates of revision surgery due to infection for InhibiZone
or non-InhibiZone treated implants among revision surgery implant patients. In this
device survival analysis with infection as the reason for the revision surgery, InhibiZone
treated AMS 700 Devices had a significantly better survival than non-InhibiZone treated
devices among revision surgery implant patients (p=0.0252) (Figure 10).
Figure 10: Device survival—freedom from revision due to infection among revision
surgery implant patients
In conclusion, this human clinical evidence from the InhibiZone PIF analysis indicates
the revisions due to infection were significantly lower among patients who received
an AMS 700 Device treated with InhibiZone when compared to a nontreated AMS 700
Device. This reduced rate of revisions subsequent to infection for the AMS 700 Device
treated with InhibiZone when compared to a nontreated AMS 700 Device was reported
for original as well as revision implants and included the high-risk subgroup of original
implant patients who had diabetes. The analysis supports the following conclusions:
• No significant differences were found between InhibiZone treated and untreated
AMS 700 Penile Prostheses for overall rates of revision due to mechanical
malfunction, fluid loss, erosion, patient dissatisfaction, or all other reasons.
• Use of InhibiZone results in a significant reduction in the rate of revision due to
device-related infection among penile prosthesis implants.
9
Black (K) ∆E ≤5.0