AMS 700(R) With INHIBIZONE(R) Approved By FDA As The Only Inflatable Penile Prosthesis Proven To Reduce Infection

Main Category: Men's health
Also Included In: Regulatory Affairs / Drug Approvals;  Sexual Health / STDs
Article Date: 17 Jul 2009 - 7:00 PDT

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American Medical Systems, Inc. (AMS) (NASDAQ: AMMD) a trusted provider of medical solutions for restoring men's and women's pelvic health, announced that its AMS 700® with INHIBIZONE® has been approved by the U.S. Food and Drug Administration (FDA) as the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision surgery due to infection.

Based on nearly seven years of post-market study data from more than 40,000 patients implanted with the AMS 700 devices, the FDA agreed that the use of INHIBIZONE treated inflatable penile prosthesis resulted in a significant reduction in the rate of revisions due to infection in patients receiving both a first-time AMS 700 implant or an AMS 700 revision implant.

For diabetic patients, who by the nature of their condition are at an increased risk of infection, the post-market study also concluded that the use of INHIBIZONE treated penile prosthesis resulted in a significant reduction in the rate of revisions due to infection in those receiving a first-time AMS 700 implant.

"The risk of infection is one of the most serious complications of penile implant surgery, and it's one that urologists routinely take great care to guard against," said Whitney Erickson, vice president and general manager for men's health at AMS. "We hope the fact that the AMS 700 is the only inflatable penile prosthesis on the market clinically proven to reduce the rate of revision surgery due to infection will give both doctors and patients greater confidence in this device as a treatment option for chronic erectile dysfunction."

The AMS 700 with INHIBIZONE is the gold standard for innovative penile implant technology and the only antibiotic-impregnated penile prosthesis on the market. The external silicone surfaces of the device's dual cylinders are impregnated with a proprietary combination of Minocycline Hydrochloride and Rifampin, which elute from the surface when implanted.

"Managing post-op infection can be quite challenging and extremely expensive for the practitioner. It is quite painful for the patient, and the only way to remedy it is to endure a second surgery to resolve device-related infection," stated Dr. Culley Carson, Rhodes Distinguished Professor of Urology and Chief of Urology, University of North Carolina Hospitals, Chapel Hill. "The AMS 700 with INHIBIZONE significantly reduces the risk of revision, even in diabetic patients, helping to ensure a higher degree of both doctor and patient satisfaction."

In addition to the AMS 700, INHIBIZONE is also provided with the AMS InVance male sling and AMS 800 artificial urinary sphincter.

Source
American Medical Systems