BIOMAG-II Study of Biotronik’s Freesolve RMS Begins Enrollment

May 13, 2024—Biotronik announced the enrollment of the first patient in the BIOMAG-II trial. The trial will evaluate the safety and clinical performance of Freesolve, the company’s new-generation resorbable magnesium scaffold (RMS), compared to a contemporary drug-eluting stent (DES). The Freesolve RMS is available in countries that recognize CE Mark approval.

According to the company, BIOMAG-II is a prospective, international multicenter randomized controlled study enrolling patients in 21 countries across Europe and the Asia-Pacific region. The study will be composed of 1,859 patients presenting with de novo coronary artery stenosis.

The study’s primary endpoint is the target lesion failure (TLF) rate at 12 months. Clinical follow-up visits will take place at 1, 6, and 12 months and annually thereafter up to 5 years post procedure.

“We are delighted to enroll the first patient in the BIOMAG-II trial, which may play a critical role in helping establish RMSs as part of clinical practice in the future and I am particularly encouraged by the implantation results of the Freesolve RMS,” commented Juan F. Iglesias, MD, who is from HUG—University Hospital Geneva in Geneva, Switzerland, in Biotronik’s press release. “Resorbable scaffolds have shown potential in reducing long-term adverse events compared to DES, marking a significant advancement in vascular intervention. We finally have a scaffold that delivers on its promise.”

In September 2023, Biotronik announced that previous BIOMAG-I study results demonstrated excellent outcomes with regard to late lumen loss and TLF at 6 and 12 months. Additionally, optical coherence tomography imaging confirmed that the Freesolve RMS struts are no longer visible at 12 months after implantation and the magnesium is fully resorbed.

Professor Michael Haude, MD, who is coordinating clinical investigator of the BIOMAG-I and II studies, will present the 24-month outcome data from BIOMAG-I at EuroPCR 2024, held May 14-17 in Paris, France.

The company advised that the Freesolve RMS is an investigational device in the United States, limited by law to investigational use. An investigation device exemption study in the United States and other international studies are in the preparation phase. These studies will build on Biotronik’s RMS experience to bring the technology to commercial availability in the United States and other global markets.