- Novel bioresorbable scaffold demonstrates primary patency rate of 97% at 3 years, indicative of long-term efficacy
- Achieved 1% post-procedural residual stenosis rate — lowest rate ever reported in a clinical trial of femoropopliteal intervention
LOS ALTOS, Calif., April 21, 2026 /PRNewswire/ — Efemoral Medical announced today that at the Charing Cross Symposium in London, UK, EFEMORAL I Principal Investigator Prof. Andrew Holden of Auckland, NZ, presented the long-term results of the first 40 patients treated with the Efemoral Vascular Scaffold System (EVSS). The results demonstrated outstanding long-term durability in patients with femoropopliteal disease, reinforcing the potential of the Company’s platform to set a new standard for endovascular treatment in this large and challenging market.
In this first-in-human study, at 3 years, the Efemoral bioresorbable scaffold delivered:
- 97% primary patency
- 97% freedom from target lesion revascularization (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 Prof. Holden, Director of Interventional Radiology, Auckland Hospital. “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.”
These long-term data build on a set of unusually strong early performance indicators, including:
- 1% ± 16% mean residual stenosis post-procedure
- 4.79± 2.0 mm minimum lumen diameter (MLD) at 6 months
- 0.43 ± 0.87 mm late lumen loss at 6 months
Patients enrolled in the EFEMORAL I clinical trial were characterized by:
- 85% of lesions located in the mid-to-distal superficial femoral artery (SFA)
- Mean lesion length of 5.5 ± 2.1 cm
- 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, MD, 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 4.79 mm at 6 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.”
About Peripheral Arterial Disease (PAD)
PAD, also known as “poor circulation” or “hardening of the arteries,” is a global plague. Worldwide, it affects approximately 200 million people[1], including an estimated 20 million people in the United States[2]. Left untreated, PAD can lead to severe disability and extremity amputation. The effectiveness of current interventional treatment remains limited, with up to 50% of conventional endovascular procedures complicated by failure or recurrence within the first year.[3]
About Efemoral Medical, Inc.
Efemoral Medical, Inc. is developing next-generation bioresorbable solutions to treat patients with vascular disease. The company’s initial product, the Efemoral Vascular Scaffold System (EVSS) with FlexStep Technology, is designed to offer a dedicated strategy for peripheral interventions. The EVSS offers a new approach to treating PAD by addressing the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg. Through the use of inter-scaffold spaces, the patented FlexStep Technology combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system easily opens vessels and sustains healthy blood flow. The novel 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. The EVSS is an OUS Investigational Device only. To learn more, please visit efemoralmedical.com.
1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6377796/
2 Yost, The True Prevalence of PAD and the Economics of Major Amputation Endovascular Today, May 2021
3 https://www.researchgate.net/publication/260118801_Nitinol_Self-Expanding_Stents_vs_Balloon_Angioplasty_for_Very_Long_Femoropopliteal_Lesions
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SOURCE Efemoral Medical
