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news.The FDA has given its go-ahead for Bioform Medical's Coaptite injectable implant for the treatment of female stress urinary incontinence to be marketed. Meanwhile, Boston Scientific has signed an agreement with Bioform making it the exclusive distributor of the product in the US.
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“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. Coaptite is a natural strategic fit for our women's health business and rounds out our product offering for the treatment of stress urinary incontinence.”
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 Coaptite Injectable Implant particles are composed of the same components that are found in bone and teeth and are biocompatible.