Endovascular Treatment of Femoropopliteal Arterial Occlusive Disease With Multiple Sirolimus-Eluting, Balloon-Expandable, Bioresorbable Vascular Scaffolds: The Efemoral Vascular Scaffold System

In a presentation on Friday morning, Ramon L. Varcoe, MBBS, MS, FRACS, PhD, MMed (Clin Epi), from Prince of Wales Hospital in Sydney, Australia, spoke about the Efemoral Vascular Scaffold System (EVSS), focusing on its innovative approach to treating femoropopliteal arterial occlusive disease. The session addressed current challenges in the treatment of these lesions and explored how the EVSS could provide solutions.

Some of the key topics covered included:

State-of-the-art of femoropopliteal Intervention:

• Overview of current methods and technologies used in treating femoropopliteal arterial occlusive disease.
• Comparison of device patency in short versus long lesions.

Bioresorbable vascular scaffolds (BVS):

• Discussion of the challenges of existing BVS technologies, including the difficulties in creating self-expanding BVS and issues with long balloon-expandable stents in deformable femoropopliteal arteries.
• Limitations of current short BVS models and their minimal clinical utility and commercial availability.

Efemoral Vascular Scaffold System (EVSS):

• Introduction of the EVSS, which features multiple short, drug-eluting, balloon-expandable resorbable elements mounted on a single delivery system.
• Deployment via balloon inflation, offering high radial strength similar to metal stents while allowing for unencumbered artery motion.
• Unique proprietary sirolimus coating for prolonged drug elution.

Clinical and animal model studies:

• Acute and chronic implantation: Results from animal models showing effective handling of arterial deformation and good initial outcomes.
• Efemoral I clinical study: Description of the prospective, single-arm, multi-center trial involving 100 patients with symptomatic peripheral arterial disease. The study aims to assess the clinical efficacy and safety of the EVSS with endpoints including Rutherford-Becker category, revascularization needs, and imaging-derived metrics.
• Index and follow-up procedures: Detailed case studies illustrating successful deployment and positive outcomes at various follow-up points, including 6 months and 9 months.

FDA Breakthrough Device Designation:

• The EVSS has received FDA Breakthrough Device Designation for treating infrapopliteal arteries in patients with critical limb threatening ischemia, highlighting its potential impact and innovative design.

In conclusion, Dr. Varcoe indicated that the EVSS represents a significant advancement as the first drug-eluting resorbable scaffold developed specifically for the peripheral vasculature. It combines the high radial strength of balloon-expandable metal stents with a segmented design that accommodates the natural movement of the femoropopliteal artery. The scaffold resolves dissection and residual stenosis while providing prolonged drug elution and complete dissolution by 2 years. Initial clinical results are promising, especially for short lesions, and there may be potential applications in tibial arteries as well.