Efemoral Medical has announced the granting of Food and Drug Administration (FDA) Breakthrough Device status for its novel Efemoral vascular scaffold system (EVSS) designed to treat de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischemia (CLTI).
Using multiple, serial, intravascular scaffolds, the device’s patented FlexStep technology combines flexibility with support to open clogged vessels and sustain healthy blood flow while accommodating tortuosity and skeletal movement, the company states.
The system is formulated with sirolimus antiproliferative drug elution, with the bioresorbable scaffolds set up to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, and maintain durable patency while leaving no permanent implant behind. The device—designed for femoropopliteal intervention—is currently being tested in a first-in-human trial, EFEMORAL I, at investigative sites in New Zealand and Australia. Encouraged by early clinical results, Efemoral Medical is now developing an additional device for treating infrapopliteal arteries in patients with CLTI.
“Diseased human arteries are most simply, reliably, and successfully treated with drug-eluting, balloon-expandable stents,” said Lewis B. Schwartz, MD, co-founder and chief medical officer of Efemoral Medical. “However,” he continued, “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.”
