Pharmaceutical Business review

FDA approves Bioform incontinence treatment, Boston secures US rights

“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.