User Information; Contents; Materials Of Animal Origin; Intended Use - Boston Scientific AMS 700 Mode D'emploi

AMS 700™ Accessory Kit
The AMS 700 Accessory Kit contains the materials needed for one implant procedure.
The Kit contains the following disposable items:
Special Purpose Needles
• Two 15-gauge disposable blunt tip needles (for filling components)
• Two 22-gauge disposable blunt tip needles (for flushing particulate matter and air
from tubing)
• One pair of Keith Needles (for transporting the cylinder traction sutures through the glans)
Hemostat Shods
• Four 13 cm lengths of tubing (for covering the tips of hemostats used to prepare
components – tubing shod hemostats help protect the prosthesis tubing from damage)
Tubing Connection Accessories
• Four straight Quick Connect Window Connectors
• Three right angle Quick Connect Window Connectors
• One collet holder with eight collets
• Three straight Suture-Tie Connectors
• Two right angle Suture-Tie Connectors
• One tubing plug (to prevent fluid from entering or leaving the prosthesis during
revision surgeries)
Proximal Tool
• This tool is designed to facilitate the insertion of the proximal portion of the cylinder
into the corpora, and may also be used to assist in closing (Figure 7).
Figure 7. Proximal Tool
InhibiZone™ Antibiotic Treatment
The InhibiZone antibiotic treatment process is intended to elute antibiotics from the
AMS 700 Device when exposed to a warm, moist environment. The dosage present
on the AMS 700 Devices is intended to act on organisms that attempt to colonize the
surface of the device. InhibiZone is a formulation of minocycline hydrochloride and
rifampin. A complete AMS 700 Device (reservoir, pump, and two cylinders) regardless
of configuration, contains ≤33 mg rifampin and ≤12 mg minocycline HCl. This represents
less than 2% of an oral dose exposure for a complete course of rifampin or minocycline
HCl, with the maximum dose calculated for the most common device configuration's
average concentration plus one standard deviation.
Clinical evidence of the InhibiZone effectiveness is provided by a post market analysis,
which included a comprehensive review of more than 43,000 patients in the Boston
Scientific (BSC) Patient Information Form database. This analysis shows a significant
improvement in the rate of revisions due to infection for patients with original or revision
AMS 700 Devices with InhibiZone (as well as patients with diabetes who received
original AMS 700 Devices with InhibiZone) compared to those who received AMS 700
Devices without the InhibiZone treatment.
Existing prophylactic antibiotic protocols should be maintained as determined by the
physician and/or institution.
Parylene Coating
Parylene coating is a medical grade polymer designed to reduce wear occurrences on
a variety of surface and texture materials. On the AMS 700 Penile Prostheses cylinders,
an innovative micro-thin Parylene coating is applied to both sides of the internal cylinder
surfaces and to the internal surface of the outer cylinder. The AMS 700 Reservoirs are
coated on the inside surface with Parylene.
The coating is 60 millionths of an inch thick. This has added millions of twist cycles in
laboratory bench testing before wear is detected.

User Information

The implantation of this device is to be performed only by physicians who are
knowledgeable regarding the use of inflatable penile prostheses. This manual is not
intended to be a complete reference.

Contents

The following is a list of the AMS 700 Penile Prostheses components and accessories:
(2) Cylinders
(1) MS Pump™
(1) Reservoir
Rear Tip Extenders: (2) 0.5 cm, (2) 1 cm, (2) 1.5 cm, (2) 2 cm, (2) 3 cm, (2) 4 cm, (2) 5 cm, (2) 6 cm
AMS 700 Accessory Kit:
(4) Straight Quick Connect Window Connectors
(3) Right Angle Quick Connect Window Connectors
(3) Straight Suture-Tie Connectors
(2) Right Angle Suture-Tie Connectors
(8) Collets
(1) Collet Holder
(2) 22 Gauge Blunt Tip Needles
(2) 15 Gauge Blunt Tip Needles
(2) Keith Needles
(4) 13 cm Lengths of Tubing
(1) Tubing Plug
(1) Proximal Tool

Materials of Animal Origin

Information concerning materials of animal origin in the AMS 700 Penile Prosthesis
components follows:
• InhibiZone treated components may contain a non-viable derivative of porcine
origin or a bovine milk derivative.
• The Quick Connect Window Connectors (straight and right angle) and the collets
contain a non-viable tallow derivative.

INTENDED USE

The AMS 700 Penile Prosthesis is designed to provide the patient with control over the
erect and flaccid states of his penis.

INDICATIONS FOR USE

The AMS 700 Penile Prosthesis is intended for use in the treatment of chronic, organic,
male erectile dysfunction (impotence).

CONTRAINDICATIONS

• The implantation of this device is contraindicated in patients who have active
urogenital infections or active skin infections in the region of surgery.
• The implantation of the InhibiZone version of this device is contraindicated in patients
with known allergy or sensitivity to rifampin, or to minocycline HCl, or other tetracyclines.
• The implantation of products with InhibiZone is contraindicated in patients with
systemic lupus erythematosus because minocycline HCl has been reported to
aggravate this condition.

WARNINGS

• The Implantation of this device will make latent natural or spontaneous erections,
as well as other interventional treatment options, impossible.
• Men with diabetes, spinal cord injuries, or open sores may have an increased risk
of infection associated with a prosthesis.
• Failure to evaluate and promptly treat erosion may result in a substantial worsening
of the condition leading to infection and loss of tissue.
• Implantation of a penile prosthesis may result in penile curvature or scarring.
• This device contains solid silicone elastomer. The risks and benefits of implanting this
device in patients with documented sensitivity to silicone should be carefully considered.
• Pre-existing abdominal or penile scarring or contracture may make surgical
implantation more complicated or impractical.
• If a hypersensitivity reaction develops to a device treated with InhibiZone, the
penile prosthesis should be removed and the patient treated appropriately.

PRECAUTIONS

Surgery-Related
• Improper reservoir placement or filling technique can result in spontaneous
unintended inflation or deflation of the cylinders that may result in unintended
partial or full erections.
• Migration of the device components can occur if the cylinders are improperly sized, if the
pump or the reservoir is not positioned properly, or if the tubing lengths are incorrect.
• Removal of an implanted prosthesis without timely reimplantation of a new
prosthesis may complicate subsequent reimplantation or may make it impossible.
• Improper measurement technique, positioning, or sizing may reduce cylinder life.
• Unsuccessful outcomes have been reported due to improper surgical technique,
anatomical misplacement of components, improper sizing and filling of components,
or tubing kinks.
• Implantation of AMS 700 LGX™ cylinders in patients with Peyronie's disease may
not provide a satisfactory result.
Device-Related
• Quick Connect Window Connectors, provided in the AMS 700 Accessory Kit, should
not be used in revision procedures involving previously implanted component tubing.
In this situation the Quick Connect Window Connectors may be less effective.
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Black (K) ∆E ≤5.0