| The U.S. Food and Drug Administration on May 9th approved BioForm Medical's Coaptite Injectable Implant for the treatment of female stress urinary incontinence.
Stress urinary incontinence is the most common type of leakage, and frequently occurs when activities such as walking, aerobics or even sneezing and coughing create added abdominal pressure that can cause urine to leak.
One approach to treating stress urinary incontinence is to inject a so-called "bulking agent" under the urethra.
The Coaptite Injectable Implant is a next-generation bulking agent. The particles are composed of the same components
found in bone and teeth and are biocompatible.
"Clinical trial results indicated fewer re-injections and less material volume versus other approved bulking agents while maintaining the durability characteristics of a synthetic product," a BioForm spokesperson said.
Meanwhile, Boston Scientific has signed an agreement with BioForm making it the exclusive distributor of the product in the US.
"Boston Scientific is excited to distribute this next-generation bulking agent," said Eric Goorno, president of the urology and gynecology businesses at Boston Scientific. "This agent is designed to offer the durability of a synthetic product in addition to procedural ease-of-use"
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