The BIOMAG-II trial compares the next-generation Freesolve scaffold to a contemporary drug-eluting stent (DES). Lake Oswego, Oregon-based Biotronik developed the scaffold for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions.
Biotronik designed its system based on the BIOmag magnesium alloy and Orsiro drug-eluting stent coating technology. The company says it delivers proven safety, improved deliverability and optimal performance, plus vessel support during and after implantation. Biotronik won FDA investigational device exemption (IDE) for Freesolve in March.
The prospective, international, multi-center trial spans 21 countries in Europe and Asia-Pacific. Biotronik aims to enroll 1,859 patients with de novo coronary artery stenosis. The trial has a primary endpoint of target lesion failure rate at 12 months.
Biotronik plans for clinical follow-up at one, six and 12 months, then annually thereafter up to five years post-procedure.
“The BIOMAG-II study marks an exciting pivot point in how we treat patients with coronary artery disease, aiming to highlight the safety and effectiveness of our Freesolve resorbable magnesium scaffold. With solid clinical evidence at our core, we’re dedicated to introducing innovative solutions that truly make a difference and enable patients to live an implant-free future,” said Dr. Georg Nollert, VP, medical affairs, Vascular Intervention at Biotronik.
