Efemoral Medical has announced the first-in-human (FIH) use of the company’s Efemoral Vascular scaffold system (EVSS) with FlexStepv technology in the EFEMORAL I FIH clinical study.
The medical device company said the technology offers a new approach to treat peripheral arterial disease (PAD), alleviate symptoms, and avoid reintervention for a historically challenging patient population.
The EVSS with FlexStep technology was specifically developed to address the anatomical challenges and complex biomechanics of patients with symptomatic PAD. The patented FlexStep technology, through the use of inter-scaffold spaces, combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system easily opens vessels and sustains healthy blood flow.
The novel bioresorbable scaffold with long-term sirolimus elution aims to deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind.
“I am pleased to enroll the first patient in the EFEMORAL I study,” commented Andrew Holden, MBChB, principal investigator and director of interventional radiology at Auckland City Hospital in Auckland, New Zealand.
“The treatment of peripheral arterial disease remains challenging as current therapies are often only temporarily effective. The system was easy to use and its unique design allows the artery to bend freely. This device has the potential to be the first safe and effective bioresorbable stent for femoropopliteal disease.”