Penile prosthesis approved by FDA to reduce device-related infection

July 30, 2009

American Medical Systems, Inc. has received FDA approval for the AMS 700 with Inhibizone as the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision surgery due to infection.

American Medical Systems, Inc. has received FDA approval for the AMS 700 with Inhibizone as the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision surgery due to infection.

The AMS 700 with Inhibizone elutes a proprietary combination of minocycline hydrochloride and rifampin from its silicone surfaces. Based on nearly 7 years of post-market study data from more than 40,000 patients implanted with the devices, the FDA agreed that the use of the drug-eluting prosthesis resulted in a significantly reduced rate of revisions due to infection in patients receiving both a first-time AMS 700 implant or revision implant.

In diabetic patients, who 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.