First-In-Human Study Begins for the Bioresorbable Efemoral Vascular Scaffold System

December 14, 2020—Efemoral Medical announced the first-in-human (FIH) use of the company’s bioresorbable, sirolimus-eluting Efemoral vascular scaffold system (EVSS) with FlexStep technology, which is designed to treat peripheral artery disease (PAD) in a broad range of patients. The device is being evaluated in the EFEMORAL I FIH clinical study, which is led by Principal Investigator Andrew Holden, MBChB, Director of Interventional Radiology at Auckland City Hospital in Auckland, New Zealand.

According to the Efemoral Medical, the EVSS with FlexStep technology was developed to address the anatomic challenges and complex biomechanics of patients with symptomatic PAD. The company’s FlexStep technology, which uses interscaffold spaces, combines flexibility with support to accommodate tortuosity and skeletal movement. The balloon-expandable deployment system easily opens vessels and sustains healthy blood flow.

The device is designed to deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind. Efemoral Medical’s EVSS is available outside the United States only as an investigational device, advised the company.

“I am pleased to enroll the first patient in the EFEMORAL I study,” commented Dr. Holden in the company’s announcement. “The treatment of PAD 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.”