American Medical (AMS), a provider of medical solutions for restoring men’s and women’s pelvic health, has announced that its AMS 700 with INHIBIZONE has been approved by the FDA
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, said the company.
AMS claimed that the AMS 700 with INHIBIZONE is the gold standard for 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. In addition to the AMS 700, INHIBIZONE is also provided with the AMS InVance male sling and AMS 800 artificial urinary sphincter.
Whitney Erickson, vice president and general manager for men’s health at AMS, said: “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. 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.”