American Medical Systems’ AMS 700 with InhibiZone—a proprietary combination of antibiotics—has received FDA’s okay to be marketed as the only inflatable penile prosthesis with clinical evidence showing a significant decrease in the need for revision surgery because of infection.

The approval was based on about seven years of postmarketing study data from more than 40,000 patients who received AMS 700 devices, according to the company.

“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,” said Culley C. Carson III, MD, who has studied the device. He is the Rhodes Distinguished Professor of Urology and Chief of Urology at University of North Carolina Hospitals in Chapel Hill.

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The external silicone surfaces of the device’s dual cylinders contain a formulation of minocycline hydrochloride and rifampin, which elute from the surface when impaired.