Efemoral Medical, a leading developer of advanced interventional therapies, has announced a significant milestone: the granting of Breakthrough Device status by the United States Food & Drug Administration (FDA) for its Efemoral Vascular Scaffold System (EVSS). This breakthrough designation applies to the treatment of de novo or restenotic lesions found in the infrapopliteal arteries of patients suffering from Chronic Limb Threatening Ischemia (CLTI).

The EVSS represents a novel approach to addressing peripheral arterial occlusive disease (PAOD), particularly focusing on the complexities of lower limb athero-occlusive conditions. Its unique FlexStep Technology utilizes multiple, sequential, intravascular scaffolds to provide both flexibility and support, effectively clearing vessel blockages and maintaining healthy blood flow. The scaffolds, infused with sirolimus antiproliferative drug elution, restore normal vessel diameter during the procedure, offering therapeutic benefits across various lesion types while ensuring long-term patency without leaving behind permanent implants.

Currently undergoing clinical trials under the EFEMORAL I study in New Zealand and Australia, the EVSS has shown promising initial results. Encouraged by these outcomes, Efemoral Medical is developing an additional device targeting below-the-knee (infrapopliteal) arteries in CLTI patients, where implanting permanent devices poses significant challenges. The EVSS introduces a unique design featuring dissolvable, drug-eluting scaffolds, enabling effective treatment of the lengthy arteries of the legs with proven drug-eluting technology.

The Breakthrough Devices Program, designed to accelerate the development, assessment, and review of innovative medical technologies, aims to provide patients with timely access to groundbreaking treatments. Approximately 10% of PAOD patients suffer from CLTI, a severe condition with a poor prognosis. The EVSS, with its potential to address unmet medical needs in this population, has earned Breakthrough Device status from the FDA.

Source: prnewswire.com

 

 

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