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US FDA Grants Approval To American Medical Systems’ AMS 700 With INHIBIZONE

American Medical Systems, Inc. has received FDA clearance for its AMS 700 with INHIBIZONE in the United States. FDA has approved the device as the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision surgery due to infection.

More than 40,000 patients were implanted with the AMS 700 devices in a post-market study. Based on nearly seven years of this study, the FDA has 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.

The 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 for people suffering from Diabetes.

“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 an antibiotic-impregnated penile prosthesis. The external silicone surfaces of the device’s dual cylinders are impregnated with a combination of Rifampin and Minocycline Hydrochloride that 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.”

AMS 700, INHIBIZONE is also offered with the AMS InVance male sling and AMS 800 artificial urinary sphincter.