BD today announced a milestone in its advanced tissue regeneration strategy and expansion efforts with successful completion of enrollment in the PREVENT clinical trial 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 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."
The PREVENT trial aims to generate clinical evidence evaluating Phasix Mesh for the prevention of incisional hernia following elective open midline abdominal surgery in patients at high risk of developing a hernia.
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.
