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Summary of Contents for Boston Scientific AMS 800
- Page 1 AMS 800™ Urinary Control System For Male Patients Instructions For Use AMS 800™ English Urinary Control System For Male Patients Instructions For Use ..........1...
- Page 2 English Catalog Number Do Not Reuse Do Not Resterilize Consult Instructions for Use Upper Limit of Temperature Sterilized Using Ethylene Oxide Sterilized Using Steam Lot Number Date of Manufacture Use by YYYY-MM-DD Manufacturer Authorized Representative in the European Community Recyclable Packaging Non-sterile CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
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Page 3: Indications For Use
The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. The AMS 800 Urinary Control System Cuff and Pump are available with InhibiZone™, an antibiotic coating of rifampin... - Page 4 AMS 800. 6. This device contains solid silicone elastomers. This device does not contain silicone gel. The risks and benefits of implanting this device in patients with documented sensitivity to silicone should be carefully considered.
- Page 5 2. Patients should be counseled in order to have a realistic expectation of the physical, psychological, and functional outcome of the implantation of an AMS 800. Although the prosthesis is designed to restore urinary control, some patients continue to have a degree of incontinence after this procedure.
- Page 6 2. Patients who receive a device with InhibiZone and are also taking methoxyflourane should be carefully monitored for signs of renal toxicity. 3. Patients who receive a device with InhibiZone and are also taking Warfarin should have their prothrombin time monitored because tetracyclines have been reported to slow coagulation.
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Page 7: Adverse Events
Adverse Events A prospective clinical study was conducted to demonstrate the safety and efficacy of the AMS 800 Urinary Control System. A total of 87 patients were enrolled in the study and 85 patients were implanted with the device. During the study, 26 patients experienced 43 device related adverse events. - Page 9 3.5 and at two-year follow-up was 4.1. The increase in mean score indicates a more positive self- esteem following AMS 800 implant. The device did not have an adverse effect on sexual function. Some patients with improved continence following implant also reported increased sexual activity.
- Page 10 Table 3 shows revision data stratified by each reported reason for revision from three different studies of male patients implanted with the AMS 800. Under the PIF Study and Retrospective Study multiple reasons were sometimes provided for a single revision. Therefore, in order to stratify this revision data by reason, all occurrences were included and presented as “% reason.”...
- Page 11 AMS 800 historical data. Based on the log-normal hierarchical model, it was estimated that the five-year revision- free rate for the AMS 800 is approximately 73.8% with 95% CI ranging from 67.3% to 79.6%. The results met the primary safety...
- Page 12 The IZ antibiotics are intended to specifically target the organisms most commonly seen in urological implant infection and cultures. The data are specific to the AMS 800 with InhibiZone treatment and should not be generalized to any other IZ (minocycline and rifampin) related devices.
- Page 13 This study compared the rates of device replacement surgery subsequent to infection or mechanical failure between IZ and Non-IZ AMS 800 devices. At the study’s conclusion survival from infection and mechanical failure of the IZ and Non-IZ device groups were compared by standard survival analysis.
- Page 14 **Relative Risk Reduction (%) = [1 – (IZ event rate / Non-IZ event rate)] x 100 Original Surgery Group Revisions Analyses OVERALL The AMS 800 PIF reports included in the survival analyses were from a total of 17,063 original implant surgeries, including 13,060 (76.5%) IZ devices and 3,742 (21.9%) Non-IZ devices.
- Page 15 Non-IZ group. Revision Surgery Group Revisions Analyses OVERALL The AMS 800 PIF data included a total of 7,194 revision implant surgeries with 4,352 (60.5%) IZ devices and 1,891 (26.3%) Non-IZ devices. The remaining 951 (13.2%) implants, a mix of IZ treated and Non-IZ components, were removed from additional statistical analysis.
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Page 16: Patient Counseling Information
IZ group demonstrated a 16.0% relative risk reduction for Infection and a 18.6% relative risk reduction for mechanical malfunction. The data demonstrate that the AMS 800 (IZ and Non-IZ) device is and remains safe and effective. Patient Counseling Information... - Page 17 AMS 700 pump without InhibiZone. The AMS 700 Pumps used in the 700 Series of Inflatable Penile Prostheses is similar to AMS 800 Pumps used in the 800 Series of Artifical Urinary Sphincters in regards to material composition, adhesive, and InhibiZone application process.
- Page 18 No such effect has been described in humans. Extensive testing has been conducted on all materials that comprise the AMS 800. This testing has indicated no toxicological response attributable to the materials. However, some of the materials caused minor irritation when implanted in animals.
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Page 19: Outside The United States
Pulse Sequence T1-SE T1-SE 5,800 1,956 6,096 2,650 Signal Void Size mm 2 mm 2 mm 2 mm 2 Plane Perpen- Perpen- Parallel Parallel Orientation dicular dicular Inventory Returns and Product Replacement Information A Patient Information Form (PIF) must be filled out and filed with AMS at the time of implant to activate the product warranty. - Page 20 U.S.A. U.S. Toll Free: 800 328 3881 Tel: +1 952 930 6000 Tel: +31 20 593 8800 ©2017 Boston Scientific Corporation or its affiliates. All Rights reserved. All trademarks are the property of the respective owners. 1004680 (P/N) 1004681 (A/W Rev A) (2017-02)
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