#United States #Los Altos #PAD #Efemoral Medical #EVSS

Pioneering Advances in Peripheral Arterial Disease Treatment

Efemoral Medical, a leader in vascular health solutions, recently unveiled remarkable long-term outcomes from its innovative clinical trial, EFEMORAL I. The trial, which evaluates the company's Efemoral Vascular Scaffold System (EVSS), marks a significant step forward in treating patients afflicted by symptomatic peripheral arterial occlusive disease stemming from atherosclerosis affecting the femoropopliteal artery. The exciting results were showcased by the principal investigator, Professor Andrew Holden, at the esteemed Charing Cross Symposium held in London.

The trial enrolled an initial cohort of 20 patients across four sites in Australia and New Zealand, revealing a strikingly low rate of reintervention at 0%. Some of the principal outcomes include:

• - A mean lesion length of 5.1 ± 2.0 mm
• - Post-procedure residual stenosis averaged at 0 ± 15%
• - Zero acute or subacute thrombosis reported
• - At a six-month follow-up, the angiographic subset demonstrated a late lumen loss of 0.41 ± 1.0 mm
• - A mean minimal lumen diameter of 4.74 ± 0.86 mm at the six-month mark
• - A median patient follow-up period of two years
• - An outstanding 100% primary patency and freedom from target lesion revascularization at three years
• - Consistent improvement in both clinical outcomes and walking tolerance over the same time frame.

Professor Holden expressed optimism regarding the trial results, stating, "The 0% post-procedure residual stenosis in EFEMORAL I is the lowest ever reported for a femoropopliteal trial." He praised the EVSS for its ease of deployment, structural integrity, and its capacity to restore the original arterial diameter during procedures without necessitating a permanent implant. Importantly, the EVSS is designed with a sustained release of Sirolimus, fostering superb long-term patient outcomes while enhancing the procedure's efficacy.

Innovative Technology Addressing Peripheral Arterial Disease

The Efemoral Vascular Scaffold System stands out due to its unique FlexStep Technology. This innovative approach caters to the intricate anatomical and biomechanical challenges faced by patients suffering from athero-occlusive disease in the legs. The EVSS employs inter-scaffold spaces to provide both flexibility and robust support, allowing for adjustments according to vessel tortuosity and skeletal motion. Its balloon-expandable deployment system not only facilitates the opening of vessels but also helps maintain healthy blood circulation.

Dr. Lewis B. Schwartz, Co-Founder and CMO of Efemoral Medical, highlighted the advantages of the EVSS, suggesting that its high radial strength and capacity for complete vessel expansion during initial procedures make it a superior choice compared to traditional methods such as balloon angioplasty or self-expanding nitinol stents.

The implications of these findings are significant. With a reported 50% failure rate among conventional endovascular procedures within the first year, the EVSS presents a reliable alternative to conventional treatment methods, aiming to revolutionize the intervention landscape for patients struggling with peripheral arterial disease (PAD).

Understanding Peripheral Arterial Disease

Peripheral Arterial Disease is a pervasive health issue affecting around 200 million individuals globally, with around 20 million in the United States alone. Often referred to as poor circulation or hardening of the arteries, PAD can result in severe disabilities if untreated, potentially leading to extremity amputations. Therefore, the continuous exploration and introduction of innovative solutions like the EVSS is vital to improving patient outcomes and enhancing the quality of life for those affected.

Efemoral Medical is committed to the development of next-generation bioresorbable interventions for vascular diseases. As evidenced by the remarkable results from the EFEMORAL I trial, the Efemoral Vascular Scaffold System represents an optimistic stride toward optimal treatment for PAD. For more information about the company and its pioneering products, visit efemoralmedical.com.