BD Completes Enrollment in Landmark PREVENT Trial Evaluating Phasix Mesh for Incisional Hernia Prevention
核心洞察
BD completed enrollment in the PREVENT trial, the first large randomized study of a resorbable mesh for incisional hernia (搜索) prevention, with 477 patients across 32 U.S. and European sites.
The trial compares Phasix Mesh (搜索) against primary suture closure in patients at high risk of hernia following elective open midline abdominal surgery.
Patients will be followed through the 24-month primary endpoint, with longer-term follow-up planned through five years to assess safety and clinical outcomes.
BD (Becton, Dickinson and Company) (搜索) announced a significant milestone in its advanced tissue regeneration strategy with the successful completion of enrollment in the PREVENT clinical trial, which is evaluating Phasix™ Mesh for the prevention of incisional hernias. The study enrolled 477 patients across 32 sites in the United States and Europe, making it the first large, randomized study evaluating prophylactic reinforcement for incisional hernia (搜索) prevention using a resorbable mesh — a common complication following abdominal surgery for which no products are currently approved.
"PREVENT reflects our commitment to extending the impact of advanced tissue regeneration into new areas of patient care," said Rian Seger, worldwide president of Surgery at BD. "By evaluating Phasix™ Mesh in hernia prevention, we are building on decades of innovation in abdominal wall surgery and generating evidence that could help broaden the role of regenerative technologies for patients at risk of post-surgical complications. We are grateful to the investigators, clinical sites and patients whose participation made this achievement possible."
Trial Design and Objectives
The PREVENT trial aims to generate robust clinical evidence evaluating Phasix™ Mesh for the prevention of incisional hernia (搜索) following elective open midline abdominal surgery in patients at high risk of developing a hernia. Investigators enrolled patients to compare the effect of BD's Phasix mesh (搜索) and primary suture closure on the rate of incisional hernias.
Incisional hernia (搜索) is a serious and relatively common postoperative complication of elective abdominal surgeries where a large incision is made through the abdominal wall. By completing enrollment, BD took a step toward expanding the Phasix label to cover the prophylactic use of the device in patients undergoing elective open midline laparotomy surgery.
Follow-Up and Regulatory Pathway
Patients will continue to be followed through the study's primary endpoint at 24 months, with longer-term follow-up planned through five years to further evaluate safety and clinical outcomes. Following completion of the primary endpoint assessments, data from the study are expected to support a planned submission to the U.S. Food and Drug Administration as part of the regulatory pathway for this indication.
Background on Phasix Mesh
BD's Phasix is a resorbable mesh. CR Bard (搜索), which BD bought for $24 billion in 2017, received FDA clearance in 2015 for Phasix in settings including hernia repair. Later, long-term data on the device confirmed the absence of mesh complications such as pain and infection. BD has faced lawsuits over adverse events allegedly linked to Bard meshes made from other materials.
BD called completion of enrollment in the clinical trial "a significant milestone in its advanced tissue regeneration strategy and expansion efforts." The company reported double-digit growth in sales of its infection prevention and advanced tissue regeneration products in the third quarter of its financial year.