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Efemoral Medical's EVSS Vascular Scaffold System Secures Breakthrough Device Designation

Efemoral Medical has achieved a significant milestone with the FDA granting Breakthrough Device status to its Efemoral Vascular Scaffold System (EVSS) for treating de novo or restenotic lesions of the infrapopliteal arteries in patients diagnosed with Chronic Limb Threatening Ischemia (CLTI). This recognition signifies a major advancement in the fields of interventional cardiology and vascular medicine.

The EVSS introduces a groundbreaking approach to managing peripheral arterial occlusive disease (PAOD) by tackling the anatomical complexities and biomechanical challenges associated with athero-occlusive disease in the leg. Central to its design is the patented FlexStep Technology, which seamlessly integrates flexibility and support to effectively open blocked vessels, sustain healthy blood flow, and accommodate skeletal movement and tortuosity.

A key feature of the EVSS is its formulation with sirolimus antiproliferative drug elution, enabling the restoration of normal vessel diameter during the procedure. This unique formulation ensures therapeutic efficacy across various lesion lengths and morphologies while maintaining durable patency, without necessitating a permanent implant.

In the realm of clinical trials, the EVSS is currently undergoing evaluation in a first-in-human trial, EFEMORAL I, at investigative sites in New Zealand and Australia. Encouraging early clinical results have prompted Efemoral Medical to expand its scope by developing a device tailored for treating below-the-knee (infrapopliteal) arteries in CLTI patients.

Peripheral arterial occlusive disease (PAOD) is a pervasive condition affecting a substantial portion of the global population aged 50 and above. Its ramifications include decreased mobility, diminished quality of life, and increased mortality rates.

In summary, the Efemoral Vascular Scaffold System (EVSS) represents a significant leap forward in the management of CLTI and peripheral arterial occlusive disease. The FDA's designation of Breakthrough Device status underscores the transformative potential of this technology in addressing critical medical needs and improving patient outcomes.


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