Penile prosthesis approved by FDA to reduce device-related 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.