FDA grants bioresorbable scaffold system its breakthrough device designation to treat infrapopliteal lesions
Efemoral Medical has received the FDA’s breakthrough device designation for its Efemoral Vascular Scaffold System (EVSS) to treat de novo and restenotic infrapopliteal lesions in patients with chronic limb threatening ischemia (CLTI).
EVSS is the California-based medical device company’s first offering in the interventional cardiology space. The bioresorbable device was first used to treat patients presenting with severe peripheral artery disease in 2020, though it was originally focused on femoropopliteal interventions. This update would specifically be used for targeting lesions found in a patient’s infrapopliteal arteries.
Efemoral Medical designed EVSS with its patented FlexStep Technology, which is flexible enough to comfortably move with the patient’s body while still providing enough support to open clogged vessels and improve blood flow. The device includes multiple intravascular drug-eluting scaffolds that leave no permanent implant behind.
“Diseased human arteries are most simply, reliably and successfully treated with drug-eluting, balloon-expandable stents,” Lewis B. Schwartz, MD, co-founder and CMO of Efemoral Medical, said in a statement. “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.”
“Peripheral arterial occlusive disease has a significant negative impact on the health of as many as 20 million Americans,” added 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 recognized the potential of the EVSS to benefit these patients by granting breakthrough device status to our device.”
EFEMORAL I, a first-in-human trial focused on using the EVSS device to treat femoropopliteal lesions, is already underway in Australia and New Zealand.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.