Efemoral Medical’s Bioresorbable Vascular Scaffold Gains FDA Breakthrough Device Designation

February 14, 2024—The Efemoral Vascular Scaffold System (EVSS) has been granted FDA Breakthrough Device status for treating de novo or restenotic infrapopliteal artery lesions in patients with chronic limb-threatening ischemia (CLTI). The FDA’s Breakthrough program is designed to expedite development, review, and access to products that may provide more effective treatment of life-threatening or irreversibly debilitating conditions.

Los Altos, California–based Efemoral Medical describes the EVSS technology as a sirolimus-eluting bioresorbable platform using multiple, serial intravascular scaffolds. The device aims to support and maintain patency while accommodating tortuosity and skeletal movement without a permanent implant.

“Diseased human arteries are most simply, reliably, and successfully treated with drug-eluting, balloon-expandable stents,” said Lewis B. Schwartz, MD, Efemoral Medical’s Co-Founder and Chief Medical Officer, in the company’s announcement. “However, it is extremely challenging to implant these permanent devices in the long and twisting arteries of the lower extremities. The EVSS uses a unique design of alternating, dissolvable, drug-eluting scaffolds that, for the first time, allows the long arteries of the legs to be treated with the same, effective, drug-eluting technology proven to be successful in multiple other vascular beds.”

Efemoral Medical notes that its femoropopliteal iteration is currently in a first-in-human study in New Zealand and Australia, and based on early results, the company is developing the device for the infrapopliteal arteries.