FDA grants breakthrough status to Efemoral's vascular device

FDA grants breakthrough status to Efemoral’s vascular device

Time Stamp: February 15, 2024 3:50 AM
Source Node: 2481374

The device works by addressing the specific anatomic challenges, as well as complex biomechanics of individuals living with athero-occlusive disease in the leg. Credit: Valerio Pardi / Shutterstock.com.

The US Food and Drug Administration (FDA) has granted breakthrough device status to Efemoral Medical’s Efemoral vascular scaffold system (EVSS).

This designation is intended for the treatment of de novo or restenotic lesions of the infrapopliteal arteries in CLTI patients.

The EVSS represents a new approach to the treatment of peripheral arterial occlusive disease (PAOD), particularly in the infrapopliteal arteries.

It works by addressing the specific anatomic challenges as well as complex biomechanics of individuals living with athero-occlusive disease in the leg.

Efemoral Medical co-founder and CEO Christopher Haig said: “PAOD has a significant negative impact on the health of as many as 20 million Americans.

“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.”

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The system utilises FlexStep Technology, which combines flexibility and support using serial, intravascular scaffolds to alleviate vessel blockages and maintain optimal blood flow, even amidst vessel bends and bodily movement.

These bioresorbable scaffolds, infused with sirolimus for anti-proliferative effects, not only reinstate the vessel’s natural diameter during the procedure but also provide therapeutic advantages across diverse lesion types and lengths.

The above-the-knee version of the device is currently undergoing a first-in-human trial, EFEMORAL I, in New Zealand and Australian sites.

Early results have been promising, prompting the development of an additional device for below-the-knee artery treatment in CLTI patients.

Efemoral Medical co-founder and CMO Lewis Schwartz said: “Diseased human arteries are most simply, reliably, and successfully treated with drug-eluting, balloon-expandable stents.

“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 released EP3522837, a method of manufacturing a radially rigid and longitudinally flexible multi-element intravascular stent, marking its tenth-issued patent across several different patent families.

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