US-based medical technology company BD has announced the US Food and Drug Administration (FDA) 510(k) clearance and commercial launch of its Phasix ST Umbilical Hernia Patch.
Phasix ST Umbilical Hernia Patch comprises Poly-4-hydroxybutyrate (P4HB), a biologically derived material, and incorporates a hydrogel barrier based on Sepra Technology.
It is the latest addition to BD’s Phasix Mesh absorbable product line and can be deployed using the same technique as traditional permanent mesh patches.
The Phasix ST Umbilical Hernia Patch is the first fully absorbable hernia patch specifically designed for umbilical hernias, offering a novel solution in hernia repair.
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 Phasix ST hernia patch features a pocket and strap design that helps in placement, positioning, and lateral fixation, and provides surgeons with material flexibility.
It imitates the form, function, and technique of the Ventralex ST Hernia Patch, a product with over two million global implants.
According to the survey data, 60% of patients prefer a non-permanent mesh, and over 70% of surgeons are open to accommodating patient preferences.
The patch is available in three sizes, enabling the repair of various umbilical soft tissue defects while meeting surgeon preferences for adequate overlap.
Live Oak, Texas-based general surgeon Robert Harrell said: “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.
“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.”
Recently, BD introduced the HemoSphere Alta, a haemodynamic monitoring platform featuring AI-driven algorithms.
The platform aims to enhance patient outcomes and streamline clinical workflows by addressing blood pressure instability and optimising blood flow during critical procedures.
HemoSphere Alta introduces the Cerebral Autoregulation Index (CAI), which is accessible via the non-invasive ForeSight IQ Sensor and the Acumen IQ Sensor.
