Teleflex Incorporated (NYSE: TFX) has initiated enrollment in the BIOMAG-III Study, a global pivotal trial evaluating the Freesolve Resorbable Magnesium Scaffold (RMS) for treating narrowed coronary arteries.

The first patient in the U.S. investigational device exemption (IDE) trial was enrolled at MedStar Health in Washington, D.C., with Dr. Itsik Ben-Dor performing the implant. The randomized controlled trial plans to enroll 1,859 patients across up to 120 sites worldwide, including up to 60 U.S. locations. The study will compare Freesolve RMS to the Xience Drug-Eluting Stent, measuring Target Lesion Failure rates at 12 months. Scaffold lengths up to 40mm will be included.

Teleflex also announced that enrollment in the separate BIOMAG-II Study completed ahead of schedule. That trial enrolled 1,861 patients across 20 countries in Europe and Asia Pacific, comparing Freesolve RMS against the Xience Drug-Eluting Stent on the same primary endpoint at 12 months.

The company separately reported four-year data from the BIOMAG-I First-In-Human Study, showing a Target Lesion Failure rate of 3.5% at four years, with no new clinical events recorded between two and four years.

Freesolve RMS is engineered to resorb within 12 months, according to the company. The device is not approved for sale in the United States and is currently available only in countries that accept CE mark. The BIOMAG-III trial is designed to support future regulatory applications.

Dr. Ron Waksman, Associate Director of Cardiology at MedStar Washington Hospital Center and steering committee chairman for the BIOMAG-III Study, and Dr. David E. Kandzari, U.S. National Principal Investigator, are both paid consultants of Teleflex.

Information in this article is based on a press release issued by Teleflex.