Efemoral Vascular Scaffold System Evaluated in Long-Term Results From FIH Trial

April 22, 2026—Efemoral Medical announced long-term results of the first 40 patients treated in the EFEMORAL I first-in-human (FIH) clinical trial of the Efemoral vascular scaffold system (EVSS).

EFEMORAL I Principal Investigator Professor Andrew Holden, MD, presented the data at the 2026 Charing Cross Symposium in London, United Kingdom. Prof. Holden is Director of Interventional Radiology at Auckland Hospital in Auckland, New Zealand.

According to the company, patients enrolled in the study were characterized by 85% of lesions located in the mid-to-distal superficial femoral artery, a mean lesion length of 5.5 ± 2.1 cm, 50% total occlusions, and 20% grade 4 calcification.

As summarized in Efemoral Medical’s press release, the FIH study demonstrated the Efemoral bioresorbable scaffold’s long-term durability in patients with femoropopliteal disease. At 3 years, the device delivered 97% primary patency and 97% freedom from target lesion revascularization. Additionally, it showed sustained improvement in ankle-brachial index, Rutherford-Becker classification, and walking tolerance.

Efemoral stated that these long-term data build on strong early performance indicators, including 1% ± 16% mean residual stenosis postprocedure, minimum lumen diameter of 4.79 ± 2.0 mm at 6 months, and late lumen loss of 0.43 ± 0.87 mm at 6 months.

“These EFEMORAL I data represent a compelling demonstration of durability in the treatment of femoropopliteal occlusive disease,” commented Prof. Holden in the company’s press release. “The combination of high patency, low reintervention, and sustained functional benefit over 3 years is highly encouraging and suggests this technology may offer meaningful advantages for affected patients without the need for a permanent implant.”

At the 2025 Charing Cross Symposium last April, Prof. Holden presented results from the initial 20 patients treated with the EVSS in the EFEMORAL I trial who were enrolled across four sites in Australia and New Zealand.