Becton, Dickinson and Company (BD) has received the US Food and Drug Administration’s (FDA) 510(k) clearance for the Phasix ST Umbilical Hernia Patch, enabling the launch of the product commercially.
This product claims to be the first fully absorbable patch tailored especially for umbilical hernia repairs.
The Phasix ST Umbilical Hernia Patch is composed of a biologically derived poly-4-hydroxybutyrate (P4HB) material and features a hydrogel barrier that is based on Sepra Technology.
BD noted that it offers an absorbable solution that can be deployed using the same techniques as traditional permanent mesh patches, while offering surgeons material optionality.
The pocket and strap design of the patch is intended to enable positioning, placement, and lateral fixation.
It is modelled after the Ventralex ST Hernia Patch, a product with a global implantation record of more than two million.
The patch is the newest addition to the company’s Phasix Mesh product line.
It is available in three sizes and allows for the repair of a wide range of umbilical soft tissue defects, catering to the preferences of surgeons for adequate overlap.
According to the company, the data from a recent survey highlights a growing patient preference for non-permanent mesh alternatives in hernia repairs, with 60% expressing this choice.
Additionally, over 70% of surgeons have indicated their willingness to consider patient preferences regarding mesh materials.
BD chief medical officer Ron Silverman said: "BD is redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs through proven, reliable alternatives to permanent mesh.
"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."
The development follows the company’s introduction of the HemoSphere Alta platform, a haemodynamic monitoring system that incorporates AI-based predictive algorithms to manage blood pressure instability, improving blood flow during medical procedures.
