Boston Scientific, BioForm Medical get FDA approval for incontinence product

By Elaine Rigoli

Tampa, Fla., May 10 - Boston Scientific Corp. and BioForm Medical, Inc. have received Food and Drug Administration approval of BioForm's Coaptite injectable implant for the treatment of female stress urinary incontinence.

The companies also announced that they have signed an agreement giving Boston Scientific exclusive distribution rights for the implant in the United States. The product is expected to launch in the United States immediately, according to a news release.

The product is designed to offer the durability of a synthetic product in addition to ease of use, officials said.

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. The combination of calcium hydroxylapatite particles and the sodium carboxymethylcellulose carrier gel form a scaffold that promotes tissue infiltration, the release said.

The Coaptite injectable implant particles are composed of the same components that are found in bone and teeth and are biocompatible.

Boston Scientific, located in Natick, Mass., develops medical devices for use in a broad range of interventional medical specialties.

San Mateo, Calif.-based BioForm is a medical device company developing and commercializing injectable implant products for soft and hard tissue augmentation.

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