Uroplasty's Macroplastique® Implants: Received USFDA Pre-Market Approval

Filed in archive Diagnostics on November 3, 2006

Uroplasty, Inc. (Amex: UPI) has already received USFDA pre-market approval (PMA) for its Macroplastique® Implants.

Uroplasty can now begin marketing Macroplastique® in the United States for the treatment of female stress urinary incontinence primarily due to intrinsic sphincter deficiency.

According to Uroplasty President and CEO, David B. Kaysen:

"We have been selling Macroplastique in Europe since 1991 and this approval allows us to commercialize the product in the United States. We expect to begin marketing this product in the United States in early 2007.

The addition of Macroplastique to the U.S. product line provides Uroplasty with the unique opportunity to treat multiple indications of voiding dysfunctions with a platform of safe and effective products."

Read the full press release (a pdf file).