BD Achieves Milestone with First Phasix™ Hernia Prevention Case in Greece

BD (Becton, Dickinson and Company) (NYSE: BDX), a prominent player in the global medical technology sector, has marked a pivotal achievement in its advanced tissue regeneration strategy. The company successfully completed the first Phasix™ Mesh laparotomy reinforcement procedure in Greece, coinciding with the product's recent expanded indication for prophylactic use in Europe. This milestone signifies the first comprehensive prophylactic application of hernia mesh for open, high-risk surgical procedures within the European Union.

Details of the First Procedure

The groundbreaking procedure took place at the George Papanikolaou General Hospital in Thessaloniki, one of northern Greece’s largest healthcare facilities. The procedure was conducted by renowned general surgeon and Associate Professor Ioannidis Orestis. A 63-year-old male patient with several risk factors underwent a sigmoidectomy, during which a Phasix™ Mesh (08 x 30 cm) was applied prophylactically at the laparotomy incision site to mitigate the risk of future hernia formation.

Progress in the U.S. PREVENT Trial

In parallel to this significant advancement, BD's PREVENT multicenter randomized controlled trial has achieved notable progress, with over 85% of its target population enrolled as of now. This trial, taking place across Europe and the United States, aims to gather robust clinical evidence supporting the utilization of bioabsorbable mesh to reduce the occurrence of incisional hernias. The study is set to provide crucial data for a Premarket Approval (PMA) submission for incisional hernia prevention in the United States, projected to reach completion in 2026.

Implications for Healthcare Costs

According to Rian Seger, the worldwide president of the BD Surgery business, "Incisional hernias affect up to 30% of patients after abdominal surgery and cost health care systems billions annually." He emphasized that with the Phasix™ Mesh, BD aims not just to repair hernias but effectively prevent them. Notably, U.K. data indicates that patients undergoing incisional hernia repairs face average costs of £23,148—almost double that of patients without such repairs. Implementing prevention strategies could lead to significant reductions in healthcare expenses and enhance the quality of life for many patients.

Phasix™ Mesh: Regulatory Approvals and Market Availability

Phasix™ Mesh has recently received CE marking approval for prophylactic indications and will see the introduction of three new sizes by 2025. The product is now registered in the U.K. and available throughout Europe, aligning with broad hernia prophylaxis indications. This development signals a crucial step towards transforming surgical best practices and delivering safer, more efficient outcomes for clinicians. It is important to note that Phasix™ Mesh is not authorized for hernia prevention use in the United States.

About BDX

BD stands as one of the largest global medical technology firms committed to advancing health through innovations in medical discovery, diagnostics, and care delivery. With over 70,000 employees, BD is dedicated to enhancing safety and efficiency in healthcare settings, aiding laboratory scientists in disease detection, and supporting researchers developing next-generation diagnostics and therapeutics. BD operates globally, partnering with various organizations to tackle pressing health challenges and improve healthcare outcomes.

Contact Information

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