User Information - Boston Scientific AMS 800 Mode D'emploi

Control Pump
The control pump (Figure 8) is implanted in the soft tissue of the scrotum or labium. It is
made of silicone elastomer and is approximately 1.3 cm wide and 3.5 cm long. The upper
part of the pump (the valve block) contains the resistor and valves needed to transfer
fluid between the components. The bottom half of the pump is a bulb that the patient
squeezes and releases to transfer fluid out of the cuff to void. The deactivation button
is located on the valve block. Pressing the deactivation button prevents fluid from being
transferred between the components. This feature allows the physician to leave the cuff
deflated for transurethral procedures, and during the postoperative period.
Figure 8. Control pump
Pressure Regulating Balloon (PRB)
The pressure regulating balloon (Figure 9), implanted in the prevesical space, controls
the amount of pressure exerted by the cuff. It is made of silicone elastomer and is
provided in the following three pressure ranges:
• 51-60 cm H O (5.0-5.9 kPa)
2
• 61-70 cm H O (6.0-6.9 kPa)
2
• 71-80 cm H
O (7.0-7.8 kPa)
2
The PRB tubing is joined to the pump tubing by a connector.
Figure 9. Pressure regulating balloon
Kink-Resistant Tubing (KRT)
Kink-resistant tubing (Figure 10) is reinforced with suture material that is either clear
or black. The tubing is color-coded to help surgeons make the correct connections
between components.
Figure 10. Pump with clear and black KRT
• Clear tubing connects the pump to the cuff.
• Black tubing connects the pump to the PRB.
KRT is connected with connectors, of which there are two types: Quick Connect
Window Connectors and Suture-Tie Connectors.
Black (K) ∆E ≤5.0
AMS 800 Accessory Kit
™
The AMS 800 Accessory Kit contains the materials needed for one implant procedure.
The kit contains the following disposable items:
Cuff Sizer
• One disposable Cuff Sizer, which aids in selection of a cuff
Special Purpose Needles
• Two 15 gauge disposable, Blunt Tip Needles
• Two 22 gauge disposable, Blunt Tip Needles
Hemostat Shods
• Two 30 cm lengths of blue silicone tubing
Tubing Connection Accessories
• Three Straight Quick Connect Window Connectors
• Two Right Angle Quick Connect Window Connectors
• One Y Quick Connect Window Connector (a 3-way connector)
• One Collet Holder with eight Collets
• Three Straight Suture-Tie Connectors
• Two Right Angle Suture-Tie Connectors
• One Y Suture-Tie Connector (3-way connector)
InhibiZone Antibiotic Treatment
™
The InhibiZone antibiotic treatment process is intended to elute antibiotics from
AMS 800 AUS component surfaces when they are exposed to a warm, moist
environment. The dosage present on the AMS 800 AUS is intended to act on organisms
that attempt to colonize the surface of the device. InhibiZone is a formulation of
minocycline hydrochloride and rifampin (rifampicin). BSC provides various component
configurations of the AMS 800 AUS to individualize treatment. However, while the
AMS 800 AUS pressure regulating balloon (PRB) is not InhibiZone treated, a complete
device (PRB, pump, and one or two cuffs), regardless of configuration, contains ≤ 6.5 mg
rifampin and ≤ 8 mg minocycline HCl. This represents less than 2% of oral dose exposure
for a complete course of rifampin or minocycline HCl with the maximum dose calculated
from the means and 95% tolerance intervals.
In vitro data presented in Table 1 are available, but their clinical significance is unknown.
No clinical studies have been performed to evaluate the effect of the antibiotic treatment
on reducing the incidence of artificial urinary sphincter implant infections.
Table 1. In Vitro Zone of Inhibition for Device Samples* with InhibiZone Treatment
Organism
Staphylococcus epidermidis
Staphylococcus aureus
Escherichia coli**
Enterococcus faecalis**
Candida albicans**
Proteus mirabilis**
*obtained using standardized kink-resistant tubing test samples containing approximately 12 µg minocycline HCl
and 26 µg rifampin
**the isolates tested were not susceptible to rifampin and/or minocycline HCl control disks
An animal infection study was conducted using 11 rabbits. Five rabbits were implanted
subcutaneously with 6 test samples each and five rabbits were implanted subcutaneously
with 6 control samples each. One rabbit received three test samples and three control
samples. The test samples were portions of an InhibiZone treated AMS 700
Penile Prosthesis pump and the control samples were portions of a standard AMS 700
pump without InhibiZone. The AMS 700 pumps used in the AMS 700 device are similar to
AMS 800 AUS pumps used in the AMS 800 Artificial Urinary Sphincter device in regards
to material composition, adhesive, and InhibiZone application process. All samples were
soaked in a 103-104 CFU solution of Staphylococcus aureus, Sheretz strain for 8 hours.
Samples were then allowed to dry for 30 minutes prior to surgical placement in the
rabbit. After 2 days, all samples were removed and observed for growth on the samples.
The number of coated samples that were infected was statistically significantly lower
than the number of control samples that were infected.
Existing prophylactic antibiotic protocols should be maintained as determined by the
physician and/or institution.

User Information

Only physicians with advanced training in urology, and management of patients in need
of an artificial urinary sphincter, shall implant the AMS 800 AUS. This manual is not
intended to be a complete reference.
4
Mean (mm) S.D. (mm) Number of Isolates
22.6 2.9 21
17.5 5.0 25
6.5 2.6 24
4.8 6.7 21
0.1 0.4 21
0.6 1.0 17
Inflatable
™