Dr. Itsik Ben-Dor, MedStar Health in Washington, D.C., is the first implanter in the United States (U.S.) in the IDE trial of Freesolve™ RMS. Designed as a pivotal trial to support future regulatory applications, the BIOMAG™‑III Study represents the most comprehensive planned clinical evaluation of Freesolve™ RMS to date.
Chairman of the steering committee of the BIOMAG™-III Study, Dr. Ron Waksmanǂ, Associate Director of Cardiology at MedStar Washington Hospital Center, stated: "I’m proud that the very first patient in the BIOMAG™-III IDE trial has been enrolled at MedStar Health. Contributing to this important international study is the first step towards potentially changing how we treat narrowed arteries, a very common condition we see in our clinics every day. Researching innovative therapies like Freesolve™ RMS is critical to advancing care for our patients."
The BIOMAG™-III Study is a randomized controlled trial (RCT). The study will enroll 1,859 patients and compare Freesolve™ RMS to Xience™ Drug‑Eluting Stent (DES) with respect to Target Lesion Failure (TLF) ratea at 12 months. The study will include scaffold lengths up to 40mm. The BIOMAG™-III Study will be conducted at up to 120 sites worldwide, including up to 60 sites in the U.S., underlining Teleflex’s strong global commitment to advancing resorbable scaffold technology.
Furthermore, enrollment recently completed ahead of schedule for the BIOMAG™-II Study (NCT05540223). This study enrolled 1,861 patients across 20 countries in Europe and Asia Pacific. The BIOMAG™-II Study is a prospective, international, multi-center, RCT comparing Freesolve™ RMS with Xience™ DES with respect to TLF ratea at 12 months. Completion of enrollment marks a major milestone for the first large‑scale, head‑to‑head RCT evaluating Freesolve™ RMS against DES.
Additionally, Teleflex recently announced positive long-term data from the BIOMAG™-I First-In-Human (FIH) Study (NCT04157153), demonstrating 3.5% TLFb at four years and no new clinical events between two and four years for Freesolve™ RMS1.