Efemoral Medical EVSS System Evaluated in EFEMORAL I FIH Trial

April 23, 2025—Efemoral Medical announced the presentation of long-term results from the initial 20 patients enrolled across four sites in Australia and New Zealand in the EFEMORAL I first-in-human clinical trial.

The trial is evaluating the performance of the Efemoral vascular scaffold system (EVSS) for the treatment of patients with symptomatic peripheral arterial occlusive disease from atherosclerosis of the femoropopliteal artery.

Professor Andrew Holden, MD, with Auckland City Hospital in Auckland, New Zealand, is Principal Investigator of the trial. Prof. Holden presented the EFEMORAL I data at the Charing Cross International Symposium 2025 held April 23-25 in London, United Kingdom.

As outlined in the company’s press release, key findings from EFEMORAL I included the following:

• Mean lesion length: 5.1 ± 2 cm
• Postprocedure residual stenosis: 0 ± 15%
• Acute/subacute thrombosis: 0%
• Late lumen loss at 6 months: 0.41 ± 1 mm (angiographic subset, n = 10)
• Mean minimal lumen diameter at 6 months: 4.74 ± 0.86 mm (angiographic subset, n = 10)
• Median follow-up: 2 years
• Primary patency at 3 years: 100%
• Freedom from target lesion revascularization at 3 years: 100%
• Sustained improvement in clinical outcome and walking tolerance at 3 years

“In this first patient experience, I found the EVSS to be simple to deploy and strong enough so that I can fully restore the original arterial lumen diameter at the time of the procedure,” commented Prof. Holden in the company’s press release. “Furthermore, it elutes a relatively high dose of sirolimus over several months, leading to excellent long-term outcomes, all without the need for a permanent implant. I’m looking forward to expanding my use of this device in more patients with more complex lesions.”

According to the company, the EVSS is designed to address the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg. The bioresorbable scaffold with long-term sirolimus elution aims to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind, noted Efemoral Medical.