Clinical Studies - Boston Scientific AMS 700 Mode D'emploi

The following "Other" adverse device events (in alphabetical order) each occurred
in less than 0.5% of the patients: Alopecia, Back Pain, Cellulitis, Depression, Diabetes
Mellitus, Epigastric Pain, Eye Disorder, Eye Pain, Fecal Incontinence, Fibrosis, Glans
Hypermobile Dorsally, Kidney Calculus, Libido Decreased, Migraine, Necrosis, Phimosis,
Photosensitivity Reaction, Pump Fixation, Thickening of the Skin, Urinary Tract Infection,
Urinary Urgency, and Vertigo.
A total of 22 patients underwent revision surgeries in the 5 year study period. Information
on device revisions is described in the Clinical Studies section.
The following adverse events (in alphabetical order) may have been associated with
the use of this product: Bleeding, Cavernosal Crossover, Exposure to Biohazardous
Material, Granuloma Formation, Ischemia, Non-Rheumatoid Arthritis Immune-Related
Tissue Disorders, Pain (which may be prolonged or severe), Perforation or Injury of
Bladder, Corpus Cavernosum, Nerve, Tunica, or Urethra, Prolonged Procedure, Seroma,
Thrombosis, Ulceration, Unretrieved Device Fragment, Vascular Compromise, Ventral
Chordee, and Vessel Trauma.

CLINICAL STUDIES

A clinical trial was undertaken to demonstrate that the AMS 700™ Penile Prosthesis
product line provides an erection that is suitable for intercourse and has acceptable rates
of surgical revision and of significant clinical events associated with the implantation
and use of these devices. This trial included only devices without InhibiZone™. This trial
was also designed to demonstrate the implantation of these devices does not negatively
impact the sexual satisfaction, psychological well-being, self-esteem, or quality of life
of patients who receive these devices. It was a prospective, multicenter cohort trial in
which the patients served as their own control. The choice of device model implanted
(i.e., AMS 700 CX, AMS 700 CX Preconnect, AMS 700 CXM, AMS 700 Ultrex™, AMS 700
Ultrex Plus) was at the discretion of the patient and implanting physician.
NOTE: The AMS 700 MS Pump™ was not available at the time the clinical study was
conducted. However, based on the similarities between the AMS 700 MS Pump and
the AMS 700 Inflate/Deflate Pump, the clinical results also apply to this new model.
NOTE: The AMS 700 LGX™ Preconnect was not available at the time the clinical study
was conducted. However, since providing the AMS 700 LGX in preconnected form is
not expected to affect the safety and effectiveness of the prosthesis, these clinical
results also apply to the new model.
NOTE: The AMS 700 CXR was not available at the time the clinical study was
conducted. However, based on the similarities between the AMS 700 CXR and the
AMS 700 CXM models, the clinical results also apply to this new model.
NOTE: The Conceal Low Profile Reservoir* was not available at the time the clinical
study was conducted. However, based on similarities between the Conceal Low Profile
Reservoir and the spherical reservoir, the clinical results also apply to this new model.
* not available in all markets.
Three hundred male patients, over 21 years of age (range 32 to 79 years), were enrolled
in this study. The majority of study participants were White (85.3%), with African
Americans making up 14.3% of the study population followed by Hispanics (0.3%). All
patients with diagnosed organic erectile dysfunction were eligible for enrollment, if they
did not present with a history of allergy/sensitivity to silicone, preexisting autoimmune
or connective tissue diseases, or active urogenital infection.
All safety-related data, diagnoses, and health status evaluations were captured on
detailed case report forms. The investigators' professional evaluation of the erections
provided by the IPPs (Inflatable Penile Prostheses) after implantation and their suitability
for intercourse was the primary efficacy endpoint. The number of surgical revisions
performed and reported by the investigators was the primary safety endpoint. Patient
self-evaluations on 4 validated outcome instruments were the secondary efficacy
endpoints (concerning quality of life, self-esteem, psychological well-being, and sexual
satisfaction and functioning).
This clinical trial provided the following results through the 5-year evaluation for the first
126 patients to reach this postsurgical follow-up.
Physician Assessment of Device Function
One hundred twenty-six devices were evaluated at the 5-year follow-up, of which 123
(97.6%) could be inflated. Of these 123 devices, all (100%) were determined to provide an
erection suitable for intercourse. However, it should be noted that this analysis does not
include the following information regarding device malfunctions: (i) 3 of the 123 devices
found to be functioning properly at the 5-year exam were surgically revised prior to this
exam to correct a mechanical malfunction and (ii) 3 additional devices not evaluated at
the 5-year follow-up exam were also surgically revised due to mechanical malfunction.
These cases of device revision are discussed further in the next section.
Surgical Revisions
The incidence of revisions was evaluated in the 126 patients with follow-up out to 5
years, as well as 16 additional patients who experienced one or more revision surgeries
and did not reach the 5-year follow-up exam. (A revision is considered any urogenital
surgical intervention that is related to the function, placement, or site reaction to the
implanted device.) Of these 142 patients, 22 (15.5%; 95% confidence interval = 21.5%)
experienced a total of 26 revision surgeries, and 120 (84.5%) were not revised.
Black (K) ∆E ≤5.0
The average time to the first revision surgery was 15 months (ranging from 0.9 months
to 60.1 months). Of the 26 revision surgeries, there were 5 revisions due to "Infection,"
2 for "Infection/ Erosion," 2 for "Migration/Malposition," 2 for "Erosion," 2 for
"Malposition," 7 for "Mechanical Malfunction," 2 for "Fibrous Capsular Complication,"
2 for "Reimplantation Following Previous Revision," and 2 due to reasons listed as
"Other." The "Other" reasons for revision surgeries included 1 for Cylinder kink/
auto-inflation and 1 for Corporal body aneurysm. In 5 of these revision surgeries, no
device components were explanted or replaced. The components were manipulated/
repositioned but were not removed.
Patient Evaluation of Quality of Life, Self-esteem, Psychological and Sexual Well-Being
In accordance with the study protocol, overall health-related quality of life (using the
Medical Outcomes Study Health Survey, MOS-20), self-esteem (using the Rosenberg
Self-esteem Scale), psychological well-being (using the Brief Symptom Inventory), and
sexual functioning and satisfaction (using the Sexual History Form) were evaluated in
patients through 2 years post-implantation. Throughout the 2-year follow-up period,
patient quality of life, self-esteem, and psychological well-being were determined to
be equivalent to the preimplant state. Sexual functioning and sexual satisfaction, on the
other hand, was significantly improved over the preimplant state.
Antibiotic Human Clinical Experience
A post market analysis was conducted to evaluate the effect of the InhibiZone antibiotic
treatment on reducing the incidence of penile implant infections, which consisted of a
comprehensive review of more than 43,000 patients in the BSC Patient Information Form
(PIF) database. This analysis shows a significant improvement in the rate of revisions
due to infection for patients with original AMS 700 Penile Prosthesis InhibiZone
implants or revision AMS 700 Penile Prosthesis InhibiZone implants compared to those
who received AMS 700 Devices without the InhibiZone treatment. Further, patients
with diabetes who received original AMS 700 Penile Prosthesis InhibiZone implants
also demonstrate significant improvements in the rate of revisions due to infections,
compared to those who received AMS 700 Devices without the InhibiZone treatment.
The data set included PIF data for patients who underwent an AMS 700 Penile Prosthesis
implant surgery in the United States from May 1, 2001, through September 1, 2007. The
most common reason for implantation of an AMS 700 Device was recorded as "organic"
on the PIFs (Table 5). Post prostatectomy, vascular disease, and diabetes were also
commonly reported as the etiology leading to the need for the AMS 700 Devices.
Table 5: Etiology for AMS 700 Implant Patients
InhibiZone
Description
#
Original AMS 700 Implant
Diabetes Mellitus* 4,977 17.7%
Peyronie's Disease 2,553 9.1%
Post Prostatectomy 7,215 25.7%
Vascular Disease 4,037 14.4%
Other 1,107 3.9%
Organic 8,185 29.2%
Total 28,074 100.0%
Revision or Replacement AMS 700 Implant
Diabetes Mellitus 1,979 16.2%
Peyronie's Disease 1,243 10.2%
Post Prostatectomy 2,016 16.5%
Vascular Disease 2,566 21.0%
Other 1,034 8.5%
Organic 3,378 27.7%
Total 12,216 100.0%
TOTAL 40,290
NOTE: None or more than one etiology could be selected for each patient; therefore,
the numbers of patients within each subgroup by etiology above may not be identical
to the number of patients in each life table analysis.
* The diabetes subgroup with an original implant was identified and analyzed as a specific high-risk subgroup.
Three patient populations were analyzed in this PIF analysis: the first group included
all patients with an AMS 700 Penile Prosthesis original implant between May 1, 2001,
and September 1, 2007. A subgroup of these AMS 700 Penile Prosthesis original implant
patients included all patients with diabetes. The third group included all patients with
an AMS 700 Penile Prosthesis revision implant (removing or replacing all or part of
an earlier implanted device) between May 1, 2001, and September 1, 2007. An event
was recorded for any revision surgery with a surgery reason recorded as infection,
mechanical malfunction, fluid loss, erosion, patient dissatisfaction, or other. Revision
surgeries were tracked through December 1, 2007, when the reporting period was
8
Non-InhibiZone Mixed
% # % # %
627 17.7% 177 18.1%
328 9.2% 102 10.4%
819 23.1% 242 24.7%
576 16.2% 120 12.3%
151 4.3% 50 5.1%
1,046 29.5% 288 29.4%
3,547 100.0% 979 100.0%
349 15.4% 63 15.2%
208 9.2% 40 9.6%
330 14.5% 68 16.4%
599 26.4% 101 24.3%
184 8.1% 34 8.2%
602 26.5% 109 26.3%
2,272 100.0% 415 100.0%
5,819 1,394