Teleflex (TFX) Initiates BIOMAG-III Trial, Reports Strong BIOMAG-I Data for Freesolve RMS
Teleflex (TFX) announced it has initiated patient enrollment in its BIOMAG-III clinical trial for the Freesolve Resorbable Magnesium Scaffold (RMS). Concurrently, the company reported promising 12-month primary patency data from its BIOMAG-I trial, which evaluated Freesolve RMS in patients with symptomatic peripheral artery disease (PAD). This dual announcement underscores Teleflex's progress in developing bioresorbable solutions for vascular interventions. The BIOMAG-I trial demonstrated an 88.5% primary patency rate at 12 months in patients with symptomatic PAD, with no device-related major adverse events. Building on these results, the BIOMAG-III study is a prospective, multi-center, single-arm trial designed to enroll up to 100 patients across 15 sites in the U.S. and Europe. The primary endpoint for BIOMAG-III is 12-month primary patency, with key secondary endpoints including freedom from target lesion revascularization (TLR) and major adverse events. Freesolve RMS aims to provide a temporary scaffold that supports vessel healing before bioresorbing, potentially reducing long-term complications associated with permanent implants.