Biotronik Begins BIOMAG-LL Trial of Freesolve RMS in Europe

February 24, 2025—Biotronik recently announced the launch of the European BIOMAG-LL trial. The study is intended to confirm the safety and clinical performance of the company’s Freesolve resorbable magnesium scaffold (RMS) for the treatment of long de novo lesions in native coronary arteries.

According to the company, BIOMAG-LL is a prospective, international, multicenter, single-arm, premarket study that will enroll 100 patients in Europe with de novo coronary artery stenosis and long lesions. The primary endpoint of the study is the target lesion failure (TLF) rate at 12 months. Patients will undergo clinical follow-up visits at 1, 6, and 12 months, as well as at 3 and 5 years after the procedure, stated the company.

BIOMAG-LL will evaluate the Freesolve RMS’s effectiveness in longer lesions with new device sizes—including the 5- and 40-mm scaffold lengths—to support a broader market release. The Freesolve RMS is CE Mark certified for shorter lesions, noted the company. Biotronik announced the launch of Freesolve RMS in Europe in February 2024.

The first patient in the BIOMAG-LL trial was enrolled by Inga Narbute, MD, at the study site of Professor Andrejs Erglis, MD, at the Latvian Center of Cardiology at Pauls Stradins Clinical University Hospital in Riga, Latvia. Professor Flavio Ribichini, MD, who is an interventional cardiologist and Director of the Division of Cardiology at the University Hospital in Verona, Italy, commented on the trial in the company’s press release.

“We are pleased to introduce the BIOMAG-LL trial as a premarket study with a particular focus on treating longer coronary lesions,” stated Prof. Ribichini. “The exceptional results in TLF rates and safety of the Freesolve scaffold in the previous BIOMAG-I trials make us confident in its potential for treating complex, long lesions.”

As noted in the press release, the 2-year follow-up data from the BIOMAG-I trial confirmed Freesolve RMS as an effective alternative to contemporary drug-eluting stents (DES). In the study, the device demonstrated consistently low rates of TLF and no findings in scaffold thrombosis, reported Biotronik.

Professor Michael Haude, MD, presented the results at EuroPCR 2024 held May 14-17 in Paris, France. Also in May 2024, Biotronik announced the launch of the BIOMAG-II randomized controlled trial to compare the clinical outcomes of the Freesolve RMS and DES.