Interventional bioresorbable therapy developer Efemoral Medical has announced the EFEMORAL I FIH clinical study, involving first-in-human use of its Efemoral Vascular Scaffold System (EVSS) with FlexStep Technology.
The technology provides a novel way to treat peripheral arterial disease (PAD), alleviate symptoms, and prevent reintervention for a historically challenging patient population.
It was developed for addressing the anatomical challenges and complex biomechanics of patients with symptomatic PAD, poor circulation, or hardening of arteries.
Using inter-scaffold spaces, the FlexStep Technology merges flexibility with support to provide tortuosity and skeletal movement, while the balloon-expandable deployment system opens vessels and maintains healthy blood flow.
Efemoral Medical co-founder and CEO Christopher Haig said: “I would like to thank Dr Holden and the entire team for their efforts and collaboration in achieving this significant milestone.
“Efemoral celebrates our next step as a clinical-stage company, and while still early in the development process, we are excited about the potential of our technology to offer a durable clinical solution to patients and physicians.”
The new bioresorbable scaffold with long-term sirolimus elution can potentially provide therapeutic benefits across all lesion lengths and morphologies, avert restenosis, and maintain patency without needing a permanent implant.
The EVSS is an OUS Investigational Device, the company noted.
Auckland City Hospital, New Zealand Interventional Radiology director and principal investigator Dr Andrew Holden said: “I am pleased to enrol the first patient in the EFEMORAL I study.
“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 the femoropopliteal disease.”