Teleflex has initiated enrollment in the BIOMAG-III Study, a landmark global pivotal trial evaluating its Freesolve Resorbable Magnesium Scaffold. The randomized controlled trial will enroll 1,859 patients at up to 120 sites worldwide, including up to 60 in the United States, and compare Freesolve RMS to Xience Drug-Eluting Stent on Target Lesion Failure at 12 months. The first U.S. patient was implanted by Dr. Itsik Ben-Dor at MedStar Health in Washington, D.C. Teleflex also announced that enrollment in the BIOMAG-II Study, a separate 1,861-patient randomized trial comparing Freesolve RMS to Xience DES across 20 countries in Europe and Asia Pacific, was completed ahead of schedule. Additionally, positive four-year data from the BIOMAG-I first-in-human study showed a 3.5% Target Lesion Failure rate with no new clinical events between two and four years.
Teleflex IncorporatedTeleflex begins enrollment in pivotal trial for Freesolve RMS, a key product development milestone.