Enrollment Completed in BIOMAG-LL Study of Teleflex Freesolve RMS in Longer Lengths

October 15, 2026—Teleflex Incorporated announced the successful completion of patient enrollment in the BIOMAG-LL clinical study.

According to Teleflex, BIOMAG-LL is evaluating the safety and clinical performance of the company’s Freesolve resorbable magnesium scaffold (RMS) in 35-mm and 40-mm lengths for the percutaneous coronary intervention treatment of de novo coronary lesions up to 38 mm. It is a premarket, prospective, international, multicenter, single-arm trial.

The primary endpoint of the BIOMAG-LL study is target lesion failure (TLF) rate at 12 months. Clinical follow-up is being conducted at 1, 6, 12, 36, and 60 months postprocedure. In February 2025, the company announced commencement of enrollment in the trial in Europe.

“In the increasingly prevalent setting of diffuse coronary artery disease, we want to avoid long, permanent stented segments where possible,” commented Professor Flavio Ribichini, MD, in the Teleflex press release. “The data generated by the BIOMAG-LL clinical study will help determine whether longer Freesolve scaffolds can expand treatment options for patients with longer lesions while supporting the broader evolution of resorbable scaffold therapy.”

The company noted that Freesolve RSM is commercially available only in countries that accept CE Mark. The company announced the CE Mark approval and launch of the device in February 2024. The current Freesolve RMS size matrix includes diameters of 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm, and lengths of 13 mm, 18 mm, 22 mm, 26 mm and 30 mm.

In addition, Teleflex stated that the 35-mm and 40-mm Freesolve scaffold lengths are included in the ongoing BIOMAG-III pivotal clinical trial, which is currently enrolling patients in the United States and other international markets. The company announced commencement the BIOMAG-III enrollment in June 2026.