Teleflex Starts Enrollment in Resorbable Magnesium Scaffold Study

Teleflex has begun enrollment in its BIOMAG-III study to evaluate its Freesolve resorbable magnesium scaffold (RMS).

The randomized controlled trial (RCT) will enroll 1,859 patients and compare the Freesolve RMS to the Xience drug-eluting stent (DES) with respect to target lesion failure (TLF) rate at 12 months. The study will include scaffold lengths up to 40 mm and be conducted at up to 120 sites worldwide, including up to 60 sites in the U.S.

Enrollment was recently completed ahead of schedule for the BIOMAG-II study, which enrolled 1,861 patients across 20 countries in Europe and Asia-Pacific. The study is an RCT comparing Freesolve RMS with Xience DES with respect to TLF rate at 12 months.

Teleflex also recently revealed positive long-term data from the BIOMAG-I first-in-human study, showing 3.5% TLF at four years and no new clinical events between two and four years for Freesolve RMS.

Freesolve RMS is designed to resorb within 12 months, potentially reducing long-term events related to permanent metallic implants. The BIOMAG-III study hopes to gather pivotal evidence needed to bring the technology to physicians and patients.

In April, the company appointed Medtronic executive Jason Weidman as its new president and CEO. Weidman took office on June 8.

Comments from Teleflex and clinicians

Dr. Ron Waksman, associate director of Cardiology at MedStar Washington Hospital Center and chairman of the steering committee of the BIOMAG-III study: “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.”

Dr. David E. Kandzari, U.S. national principal investigator for the BIOMAG-III Study, chief, Piedmont Heart Institute, and chief scientific officer, Piedmont Healthcare: “The BIOMAG‑III Study represents an important milestone in the evolution of resorbable technologies. Freesolve RMS technology has shown positive outcomes in the BIOMAG-I FIH trial, with a plateauing of clinical events after resorption. This has long been the vision of resorbable scaffolds.”

Prof. Dr. Georg Nollert, VP Medical Affairs, Teleflex: “The BIOMAG‑III Study is a pivotal trial designed not only to meet rigorous regulatory standards, but also to demonstrate the long‑term safety and efficacy of a fully resorbable magnesium scaffold for patients, physicians, and healthcare systems. We believe Freesolve RMS has the potential to reshape the coronary intervention landscape, and the BIOMAG‑III Study could be the catalyst to drive that.”