BD Achieves First Prophylactic Hernia Prevention Case in Europe with Phasix Mesh as PREVENT Trial Nears Completion
核心洞察
BD (搜索) completed the first prophylactic Phasix Mesh (搜索) laparotomy reinforcement case in Greece, marking the first broad prophylactic hernia mesh indication across open, high-risk procedures in the European Union.
The company's PREVENT multicenter randomized controlled trial has enrolled over 85% of its target population and is projected to complete enrollment in 2026 to support U.S. regulatory submission.
Incisional hernias affect up to 30% of patients after abdominal surgery, with U.K. data showing repair costs averaging £23,148 per patient—nearly double that of patients not requiring repair.
BD (搜索) (Becton, Dickinson and Company) has achieved a significant milestone in hernia prevention with the completion of the first Phasix™ Mesh prophylactic case in Greece, representing the first broad prophylactic indication for hernia mesh across open, high-risk procedures in the European Union. The procedure was performed at George Papanikolaou General Hospital (搜索) of Thessaloniki by general surgeon and Associate Professor Ioannidis Orestis on a 63-year-old male patient with multiple risk factors undergoing sigmoidectomy.
Clinical Implementation and Procedure Details
The prophylactic procedure involved placing an 08 x 30 cm Phasix™ Mesh at the laparotomy incision site to reduce the likelihood of future hernia development. This case marks the practical implementation of BD (搜索)'s expanded European indication for prophylactic use, following the product's CE marking approval for the prophylactic indication in 2025.
The Phasix™ Mesh is now registered in the U.K. and available across Europe for broad hernia prophylaxis indications, representing what BD (搜索) describes as "a pivotal step toward redefining surgical best practices." However, the product is not indicated for hernia prevention use in the United States.
PREVENT Trial Progress and Regulatory Strategy
BD (搜索)'s PREVENT multicenter randomized controlled trial, conducted across sites in both Europe and the United States, has treated over 85% of its target population and is projected to complete enrollment in 2026. The study aims to provide robust clinical evidence supporting prophylactic bioabsorbable mesh placement to reduce the incidence of incisional hernias while supporting PMA submission for an incisional hernia (搜索) prevention indication in the United States.
Clinical Need and Economic Impact
The clinical significance of hernia prevention is underscored by substantial patient burden and healthcare costs. According to Rian Seger, worldwide president of the BD (搜索) Surgery business, "Incisional hernias affect up to 30% of patients after abdominal surgery and cost health care systems billions annually."
Recent U.K. data demonstrates the economic impact of incisional hernias, with patients who undergo incisional hernia (搜索) repair incurring an average cost of £23,148—nearly double that of patients who do not require repair. These prevention strategies have the potential to significantly reduce healthcare costs while improving patient quality of life.
Product Development and Market Expansion
Phasix™ Mesh received CE marking approval for the prophylactic indication and launched three new sizes in 2025. The product expansion reflects BD (搜索)'s commitment to what Seger describes as moving beyond repair to prevention: "With Phasix™ Mesh, we're not just repairing hernias—we're preventing them. This milestone reflects our commitment to improving long-term patient outcomes."
The development represents part of BD (搜索)'s broader advanced tissue regeneration strategy, positioning the company to address preventive surgical interventions in high-risk patient populations across European markets while building evidence for potential U.S. market entry.