Efemoral Medical Reports Exceptional Long-Term Results for its Scaffold System

Efemoral Medical is sharing positive study data for the Efemoral Vascular Scaffold System (EVSS), which offers physicians a dedicated strategy for peripheral interventions.

Results from the first 40 subjects treated with the scaffold show outstanding long-term durability in patients suffering from femoropopliteal disease, reinforcing the potential of the company’s platform to set a new standard for endovascular treatment.

Three-year data from the first-in-human EFEMORAL I study showed the 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. Andrew Holden, director of Interventional Radiology at Auckland Hospital in New Zealand. “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 strong early performance indicators, including:

• 1% ± 16% mean residual stenosis post-procedure
• 4.79± 2.0 mm minimum lumen diameter (MLD) at six months
• 0.43 ± 0.87 mm late lumen loss at six 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,” Efemoral Medical Co-Founder/Chief Medical Officer Lewis B. Schwartz, M.D., stated. “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 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.”

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

“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,” Efemoral Medical Co-Founder/CEO Christopher Haig commented. “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.”

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, offers 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 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 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.

References
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