Clinical Studies; How Supplied; Handling And Storage; Operational Instructions - Boston Scientific AMS Ambicor Mode D'emploi

CLINICAL STUDIES

A clinical trial was undertaken to demonstrate that the AMS Ambicor
Prosthesis 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 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, multi-center cohort trial in which the patients served as their own control.
One hundred and seventy-nine (179) male patients, over 21 years of age (range 31 – 81
years), were enrolled and implanted in this study. The majority of study participants
were White (66.5%), with African Americans making up 27.4% of the study population
followed by Hispanics (3.4%), Indians (1.1%), Asians (0.6%), Native Americans (0.6%),
and participants from the Middle East (0.6%). 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 device after implantation and its 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 four 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 18-month evaluation for the
first 141 patients to reach this post-surgical follow-up. Some patients were studied for
longer than 18 months.
Physician Assessment of Device Function
The function of 141 implanted devices was evaluated on or after the 18-month follow-up
exam. Of these 141 devices, 140 could be inflated (99.3%). The device that could not be
inflated was surgically replaced. All of the 140 devices that were successfully inflated
were determined to provide an erection suitable for intercourse. This assessment
of device function does not include the following information regarding device
malfunctions: Of the 140 devices found to be functioning properly on or after 18 months,
2 required revision surgery prior to this evaluation to correct a mechanical malfunction.
These and other cases of revision surgery are discussed in the next section.
Surgical Revisions
The incidence of revisions was evaluated in the 141 patients with follow-up out to at
least 18 months, and an additional 6 patients who were explanted prior to 18 months
and subsequently discontinued from the study. A revision is considered any urogenital
surgical intervention that is related to the function, placement, or site reaction to the
implanted device. Of these 147 patients, 14 (9.5%) experienced a total of 15 revision
surgeries, and 133 (90.5%) have not been revised.
The average time to the first revision surgery was 12 months (ranging from 0 to
50 months). Of the fifteen (15) revision surgeries, there were six (6) revisions due to
"Mechanical Malfunction", five (5) due to "Infection", one (1) due to "Migration/
Extrusion" (pump migration and cylinder aneurysm/bulging/extrusion), one (1) due to
"Malposition", one (1) due to "Phimosis", and one (1) due to "Patient Dissatisfaction".
Patient Evaluation of Quality of Life, Self-esteem, Psychological and Sexual Well-Being
No decline in overall patient quality of life, self-esteem, psychological well-being,
sexual functioning, or sexual satisfaction was demonstrated during this clinical trial.
The psychological well-being of these patients, as judged by the Brief Symptom
Inventory, was determined to be equivalent to the pre-implant state. The self-esteem of
the patients, as evaluated by the Rosenberg Self-Esteem Scale, was also equivalent to
the pre-implant state. The sexual functioning and sexual satisfaction did improve from
the pre-implant state, as measured by the Sexual History Form.

HOW SUPPLIED

The AMS Ambicor Penile Prosthesis and RTEs are provided sterile in a fluid-filled pouch.
The prosthesis is preconnected and prefilled. The RTEs are packaged with the prosthesis.
• Do not use if package is open or damaged.
• Do not use if labeling is incomplete or illegible.
• Do not use the device if past the "Use By" date.

Handling and Storage

Store in a cool, dry, dark place at room temperature.
Black (K) ∆E ≤5.0
Supplemental Surgical Tools
Inflatable Penile The following Boston Scientific surgical tools used to help facilitate implantation of the
™
AMS Ambicor Penile Prosthesis may be ordered separately.
The following tools are provided non-sterile and must be sterilized before use (for
reprocessing information, refer to the instructions manual provided with the tools):
• Sizer
Contents:
(1) 9.5 mm Sizer
(1) 12 mm Sizer
• Furlow Insertion Tool
• Closing Tool
The following are provided sterile and are intended for single use only:
• Proximal Tool (dual use for cylinder insertion and closing)
• Disposable Dilators
• SKW Deep Scrotal Retraction System
Required Materials
Instruments normally required for a urological surgical procedure are recommended. In
addition to the AMS Ambicor Penile Prosthesis, RTEs, and Keith Needles, the following
sterile setup is needed:
• Corporal length measuring tool
• Furlow Insertion Tool for passing traction sutures through the glans
• Disposable Dilators or a set of corporal dilators
• Sterile surgical stand (Mayo stand) or a stainless steel tray
• Basin of sterile normal saline
• Antibiotic solution for irrigation

OPERATIONAL INSTRUCTIONS

Pre-procedural Instructions

Prepare the Patient
Before surgery, take adequate steps to limit the risk of postoperative infection.
Once the patient is in the operating room, shave the abdominal and genital area. Following
the shave, scrub the area using the approved hospital preoperative scrub procedure.
Establish the sterile field, drape, position, and prepare the patient so that a penoscrotal
incision can be made.

Procedural Instructions

The following description is an overview of the penoscrotal surgical approach. This
approach leaves the incision well-hidden and provides convenient access to the
corpora cavernosa. Throughout the procedure, the surgical site may be flushed with
copious amounts of broad-spectrum antibiotics.
Dilate and Size
1. Place a Foley catheter to facilitate identification of the urethra.
2. Some physicians use the SKW Deep Scrotal Retraction System to place the penis
on "stretch" and to provide exposure of the corpora.
3. Make a 2 cm to 3 cm incision through the median raphe of the scrotum at the
penoscrotal junction. Some physicians prefer a high scrotal incision for better
proximal corporal access. Laterally retract the corpus spongiosum to avoid
damaging the urethra.
4. Dissect through to Buck's fascia to expose the tunica albuginea. Place stay sutures
to use as a reference point when measuring the corpora. Make an incision into one
of the corpora cavernosa.
5. Dilate the proximal corpus (crus) and the distal corpus to create a space for
inserting a penile cylinder. Dilate the corpus cavernosum to 13 mm-16 mm.
Note: The available AMS Ambicor Penile Prosthesis cylinder diameters are
12.5 mm, 14 mm, and 15.5 mm.
After dilating one corpus cavernosum, incise and dilate the adjacent corpus
cavernosum following the same procedure. If the corpora cavernosa are unevenly
sized or the measuring tool cannot reach mid glans, consider dissecting through the
fibrotic tissue as needed.
6. To select the cylinders and rear tip extenders (if needed) to fit the patient's anatomy,
measure each corpus length proximally and distally using a corporal length
measuring device (See the Sizing section for choosing the cylinder size). As a
general rule, the corporotomy is best placed when two-thirds of the total corporal
measurement is distal to the incision and one-third is proximal. This facilitates the
placement of the cylinders, and may avoid the need to extend the corporotomy
during the procedure.
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