Global BIOMAG III Pivotal Trial of the Teleflex Freesolve RMS Begins Enrollment 

June 29, 2026—Teleflex Incorporated announced the beginning of enrollment in the BIOMAG III global study evaluating the company’s Freesolve resorbable magnesium scaffold (RMS).

According to the company, the BIOMAG-III randomized controlled trial will enroll 1,859 patients at up to 120 sites worldwide, including up to 60 sites in the United States. The study will include scaffold lengths up to 40 mm.

Investigators will compare the Freesolve RMS to a drug-eluting stent (Xience DES, Abbott) with respect to the 12-month rate of target lesion failure (TLF) (defined as a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, or clinically driven target lesion revascularization).

The company noted that BIOMAG III, which is being conducted under an investigational device exemption (IDE), is designed as a pivotal trial to support future regulatory applications. In the United States, the Freesolve device is not approved for sale and is limited by law to investigational use.

Freesolve RMS, which is clinically often referred to as the Dreams 3G RMS, is commercially available only in countries that accept CE Mark.

Teleflex also advised that enrollment for the BIOMAG-II study was recently completed ahead of schedule. The study enrolled 1,861 patients across 20 countries in Europe and Asia Pacific. BIOMAG-II is a prospective, international, multicenter randomized controlled trial comparing Freesolve RMS with the Xience DES with respect to the TLF rate at 12 months.

The company further noted that it recently announced long-term data from the BIOMAG-I first-in-human study demonstrating 3.5% TLF (defined as a composite of target-vessel myocardial infarction, clinically driven target lesion revascularization, and cardiac death) at 4 years and no new clinical events between 2 and 4 years for Freesolve RMS. The data were presented in May 2026 at EuroPCR.