- BDX launches the first fully absorbable hernia patch for umbilical hernias.
- FDA 510(k) clearance achieved; product aligns with 60% of patient preferences for non-permanent mesh.
- Phasix™ family demonstrates success with over 385,000 implants worldwide.
BD (NYSE: BDX), a global leader in medical technology, has announced the FDA 510(k) clearance and launch of the Phasix™ ST Umbilical Hernia Patch. This groundbreaking product is the first fully absorbable hernia patch, specifically designed to address umbilical hernias, offering a unique solution that aligns with patient preferences for non-permanent mesh options.
The Phasix™ ST Umbilical Hernia Patch is crafted from Poly-4-hydroxybutyrate (P4HB), a biologically derived material, integrated with a Sepra® Technology hydrogel barrier. This innovative combination allows for the maintenance of traditional surgical techniques used with permanent mesh patches, facilitating its adoption by healthcare professionals.
BD's latest product introduction targets a significant unmet clinical need, as survey data indicates that 60% of patients prefer non-permanent mesh options, while 70% of surgeons are open to accommodating these preferences. This positions BD to capture a notable share in the umbilical hernia repair segment.
The Phasix™ family of products has already achieved global success, with over 385,000 implants and more than 85 clinical publications supporting its efficacy across 4,000 patients. The availability of the Phasix™ ST Umbilical Hernia Patch in three sizes ensures comprehensive coverage, addressing various umbilical soft tissue defects.
Ron Silverman, chief medical officer for BD, emphasized the company's ongoing commitment to redefining tissue repair through advanced biomaterials and expanding treatment options to meet individual patient needs. The launch of the Phasix™ ST Umbilical Hernia Patch further strengthens BD’s position as a leader in innovative biomaterial science, driving transformative advancements in tissue reconstruction.
