Efemoral Medical has announced that Andrew Holden (Auckland City Hospital, Auckland, New Zealand), EFEMORAL I principal investigator, presented three-year results of the first 40 patients treated with the Efemoral vascular scaffold system (EVSS) at the 2026 Charing Cross (CX) Symposium (21–23 April, London, UK).
According to the company, the results demonstrated “outstanding long-term durability” in patients with femoropopliteal disease.
In this first-in-human study, at three years, the Efemoral bioresorbable scaffold delivered:
- 97% primary patency
- 97% freedom from target lesion revascularisation (TLR)
- Sustained improvement in ankle-brachial index (ABI)
- Sustained improvement in Rutherford-Becker (RB) classification
- Sustained improvement in walking tolerance
“These EFEMORAL I data represent a compelling demonstration of durability in the treatment of femoropopliteal occlusive disease,” said Holden. “The combination of high patency, low reintervention and sustained functional benefit over three years is highly encouraging and suggests this technology may offer meaningful advantages for affected patients without the need for a permanent implant.”
Efemoral Medical notes that these long-term data build on a set of “unusually strong” early performance indicators, including:
- 1±16% mean residual stenosis post-procedure
- 4.79±2mm minimum lumen diameter (MLD) at six months
- 0.43±0.87mm late lumen loss at six months
Patients enrolled in the EFEMORAL I clinical trial were characterised by:
- 85% of lesions located in the mid-to-distal superficial femoral artery (SFA)
- Mean lesion length of 5.5±2.1cm
- 50% total occlusions
- 20% Grade 4 calcification
“The balloon-expandable scaffolds of the EVSS have high radial strength allowing for a more complete expansion of the artery at the index procedure,” said Lewis B Schwartz, co-founder and CMO of Efemoral Medical. “No residual stenosis means that the lumen of the vessel has been restored to its original diameter and is a predictor of long-term patency. The 1% post-procedure residual stenosis in EFEMORAL I is the lowest ever reported for a femoropopliteal trial while the mean minimal lumen diameter of 4.79mm at six months is the highest ever reported. Given these encouraging initial results, we have expanded the EFEMORAL I trial into more hospitals, more investigators and longer lesions.”
“We believe these results underscore the differentiated performance of the Efemoral platform with its unique design of segmented, dissolvable, drug-eluting scaffolds and its potential value in the treatment of femoropopliteal disease,” said Christopher Haig, co-founder and CEO of Efemoral Medical. “Delivering 97% primary patency and 97% freedom from TLR at three years, together with sustained functional improvement, is a powerful signal of long-term efficacy. These data strengthen our confidence in the potential of this resorbable technology.”
