FDA Clears Phasix ST Patch

"I've been waiting and hoping for this product to come to market for many years, and I'm thrilled that it's finally here for us to use," said Dr. Robert Harrell, a general surgeon from Live Oak, Texas. "The combination of the unique features of the Ventralex ST Hernia Patch with the bioabsorbable nature of Phasix™ Mesh is a wonderful fusion of technology." 

Composed of Poly-4-hydroxybutyrate (P4HB), a biologically-derived material, with the added benefits of a proven hydrogel barrier based on Sepra Technology, Phasix ST Umbilical Hernia Patch offers a unique absorbable solution to umbilical hernia repair. 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.

Recent survey data indicates that 60% of patients prefer a non-permanent mesh for hernia repair option, and more than 70% of surgeons would be willing to respond to patient mesh preferences. Phasi xST Umbilical is the latest addition to BD's growing family of Phasix Mesh absorbable products; a portfolio with over 385,000 implants globally,  peer-reviewed in more than 85 clinical publications, with over 4,000 patients studied and proven clinical outcomes.  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.