BD today announced 510(k) clearance from the FDA and the commercial launch of Phasix ST Umbilical Hernia Patch, which the company is calling the first fully absorbable hernia patch on the market designed specifically for umbilical hernias.
The patch is composed of Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, with a hydrogel barrier based on Sepra Technology. It can be deployed using the same technique surgeons use with a traditional permanent mesh patch, while providing material optionality. The pocket and strap design facilitates placement, positioning, and lateral fixation, and is designed to duplicate the form, function, and technique of the Ventralex ST Hernia Patch – a product family with more than two million implants globally.
Phasix ST Umbilical is the latest addition to BD's growing family of Phasix Mesh absorbable products; a portfolio with more than 385,000 implants globally. Available in three sizes, this patch enables the repair of a broad spectrum of umbilical soft tissue defects while accommodating surgeon preferences for adequate overlap.
