Efemoral Medical is a 2022 Rosenman Innovator and developer of the Efemoral Vascular Scaffold System (EVSS) for the treatment of peripheral arterial disease. It has been granted Breakthrough Device Designation by the FDA for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in patients with Chronic Limb Threatening Ischemia (CLTI).
From the press release:
LOS ALTOS, Calif., Feb. 14, 2024 /PRNewswire/ — Efemoral Medical, developer of advanced interventional bioresorbable therapies, today announced that the United States Food & 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 Ischemia (CLTI).
The Efemoral Vascular Scaffold System (EVSS) offers a new approach to treating peripheral arterial occlusive disease (PAOD) 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 above-the-knee (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 below-the-knee (infrapopliteal) arteries in patients with CLTI.