Incontinence

Uroplasty gets U.S. FDA market approval for Macroplastique implants for female incontinence

Published in Women's Health Weekly, November 30th, 2006

Uroplasty, Inc. (UPI) announced that it received from the U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for its Macroplastique Implants. With this approval, Uroplasty can begin marketing Macroplastique in the United States for the treatment of female stress urinary incontinence primarily due to intrinsic sphincter deficiency.

Following market introduction, the company will conduct customary, FDA-required post approval studies to obtain market feedback on safety and effectiveness of the product.

Uroplasty President and CEO David B. Kaysen commented, "We have been selling Macroplastique in Europe since 1991 and this approval allows...

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Source: Women's Health Weekly (2006-11-30)

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