Uroplasty, Inc. has announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) relating to its pre-market approval (PMA) application for Macroplastique Implants for the treatment of female stress urinary incontinence (SUI).
The receipt of the approvable letter follows FDA's completion of the scientific review of the safety and efficacy of Macroplastique. The FDA determined that the PMA is approvable subject to Uroplasty's manufacturing facilities, methods and controls being audited by the FDA and in compliance with applicable Quality System Requirements. The FDA is currently auditing Uroplasty's manufacturing facilities in Minneapolis, Minnesota and Eindhoven, The Netherlands.
David B. Kaysen, Uroplasty's President and CEO, commented, "Macroplastique is already a market leader and a preferred treatment outside the U.S. for SUI resulting primarily from intrinsic sphincter deficiency. Since its introduction in Europe, over 60,000 people have been treated with Macroplastique and numerous clinical publications reinforce the safety and efficacy of this product. I am pleased that our development efforts, now supported by the FDA's scientific review of our safety and clinical data, are bringing us within clear sight of PMA approval and the ability to market this product in the United States. Our direct sales team is excited about adding Macroplastique to our platform of voiding dysfunction products. With this response from the FDA, we will begin preparing for the launch of Macroplastique across the U.S."
With her extensive company history and direction of these PMA clinical studies, Susan Hartjes Holman, Uroplasty's Chief Operating Officer, is extremely pleased with FDA's decision. "This moves us into the final stages of FDA approval and toward our goal to bring this exceptional product to the thousands of women in this country who can benefit from Macroplastique's proven safety and performance ... an effective, non-surgical treatment for a frustrating and often embarrassing condition affecting women's lifestyle, relationships and emotional well-being. Women with stress urinary incontinence may have endured their condition for years, many still having bladder control problems after previous surgical treatments. The approvable letter represents the efforts of so many of our employees worldwide. I am very proud to be associated with this product and the dedicated, capable staff at Uroplasty."