Efemoral Medical today announced that the US Food and Drug Administration (FDA) has granted its novel Efemoral vascular scaffold system (EVSS) Breakthrough Device status for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with chronic limb-threatening ischaemia (CLTI).
A press release states the EVSS offers a new approach to treating peripheral arterial occlusive disease by addressing the specific anatomic challenges and complex biomechanics of patients with athero-occlusive disease in the leg. Using multiple, serial, intravascular scaffolds, the patented FlexStep technology combines flexibility with support to open clogged vessels and sustain healthy blood flow while accommodating tortuosity and skeletal movement.
Formulated with sirolimus antiproliferative drug elution, the bioresorbable scaffolds 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, in investigative sites in New Zealand and Australia. Encouraged by the 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, co-founder and CMO 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.”
The Breakthrough Devices programme is reserved for novel medical technologies that potentially provide for more effective diagnosis and/or treatment of life-threatening or irreversibly debilitating diseases. It is intended for patients to enjoy more timely access to novel devices by expediting their development, assessment, and review.
“Peripheral arterial occlusive disease has a significant negative impact on the health of as many as 20 million Americans,” said Christopher Haig, co-founder and CEO of Efemoral Medical. “It is especially devastating for those 10% of patients suffering from its most severe form, CLTI. We are extremely gratified that the FDA has recognised the potential of the EVSS to benefit these patients by granting Breakthrough Device status to our device.”
