BD Rolls Out Bioabsorbable Mesh for Hernia Repair After FDA Nod

BD (Becton, Dickinson and Company) has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for and launched its Phasix ST umbilical hernia patch. According to BD, it’s the first and only fully absorbable hernia patch on the market designed for umbilical hernias.

Phasix ST is composed of the biologically-derived material Poly-4-hydroxybutyrate (P4HB) with a hydrogel barrier based on Sepra technology. It can be deployed with the same technique as a traditional permanent mesh patch and offer material optionality.

A pocket and strap design eases placement, positioning, and lateral fixation, and is designed to duplicate the form, function, and technique of the Ventralex ST hernia patch. Phasix ST is available in three sizes, and the patch allows repair of a variety of umbilical soft tissue defects while accommodating surgical preferences.

BD said data on file showed 60% of patients prefer a non-permanent mesh for hernia repair, and over 70% of surgeons are willing to respond to patient mesh preferences. Phasix ST is latest addition to the company’s growing family of Phasix mesh absorbable products.

“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.”

“BD is redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs through proven, reliable alternatives to permanent mesh,” added Ron Silverman, chief medical officer for BD. “This marks another milestone in hernia repair innovation and further positions BD as a leader in advanced biomaterial science – driving transformative change in tissue reconstruction.”

Yesterday, BD launched HemoSphere Alta, an advanced hemodynamic monitoring platform with predictive artificial intelligence (AI)-based algorithms to help proactively address blood pressure instability and optimize blood flow.