Biotronik’s Freesolve RMS Shows Safety and Efficacy at 2 Years in BIOMAG-I Study

May 17, 2024—Biotronik announced 2-year follow-up data from the BIOMAG-I first-in-human trial for Freesolve, the company’s third-generation resorbable magnesium scaffold (RMS). The data confirm the reliable and predictable long-term safety profile for the device, establishing it as an alternative to contemporary drug-eluting stents (DES).

At the 24-month follow-up, the incidence of target lesion failure (TLF) was 3.5% with a 3.5% incidence of target lesion revascularization (TLR), which compares favorably with various second-generation DES. There were no cases of myocardial infarction (MI), cardiac death, or definite/probable scaffold thrombosis.

Professor Michael Haude, MD, presented the results at EuroPCR 2024 held May 14-17 in Paris, France. Prof. Haude is from Rheinland Klinikum in Neuss, Germany.

“At this 2-year time point, the Freesolve RMS with its new magnesium alloy, which allows for increased radial strength, showed again excellent clinical and safety,” commented Prof. Haude. “With this highly competitive device, we’re advancing toward a randomized trial—BIOMAG-II—to compare the advantages of a fully resorbable implant to a permanent DES that remains in the artery indefinitely.”

The initial findings from the BIOMAG-I study were announced in September 2023. At the 1-year follow-up, the study revealed excellent late lumen loss outcomes at both 6 and 12 months. Additionally, the findings confirmed that the Freesolve RMS achieves complete absorption within 12 months postimplantation because of its Biomag magnesium alloy.

On May 13, Biotronik announced the initiation of the BIOMAG-II prospective, international, multicenter randomized controlled trial. The study aims to evaluate the safety and clinical performance of the new-generation Freesolve RMS compared to a contemporary DES. The study is primarily evaluating the TLF rate during a 12-month period with consecutive follow-ups.