Thursday, medical device maker American Medical Systems, Inc. (AMMD) said its AMS 700 with Inhibizone has been approved by the U.S. Food and Drug Administration as the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision surgery due to infection.
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.
American Medical said it took seven years of post-market study on more than 40,000 patients implanted with the AMS 700 devices and the FDA agreed that the use of Inhibizone treated inflatable penile prosthesis resulted in a significant reduction in the rate of revisions.
In the case of diabetic patients, who are at an increased risk of infection, the post-market study 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 company noted that the AMS 700 with Inhibizone is the gold standard for innovative penile implant technology and the only antibiotic-impregnated penile prosthesis on the market.
Culley Carson, Professor of Urology and Chief of Urology, University of North Carolina Hospitals said, "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."
AMMD is currently trading at $16.43, up $0.58 or 3.66%, on a volume of 0.373 million shares on the Nasdaq.
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