Endologix DETOUR2 Study’s 24-Month Results Presented

June 15, 2023—Endologix LLC announced the 24-month results from the DETOUR2 study of the company’s Detour system, which recently received FDA approval for percutaneous transmural arterial bypass (PTAB) to treat patients with complex peripheral artery disease (PAD).

The DETOUR2 study enrolled 202 patients in the United States and Europe. Of enrolled patients, 96% had chronic total occlusions with a mean lesion length of 32.7 cm. Technical success was achieved in 100% of treated patients and the primary safety endpoint was surpassed with a 30-day major adverse event rate of 7%.

The 24-month data were presented by Sean Lyden, MD, at the VAM23, the Vascular Annual Meeting of the Society of Vascular Surgery held June 14-17 in National Harbor, Maryland.

As outlined in the Endologix press release, Dr. Lyden presented the following 24-month results:

• Freedom from clinically driven target lesion revascularization was 76.7%.
• Secondary patency was 82.3%.
• Freedom from symptomatic deep vein thrombosis was 96.5%.
• Freedom from major lower limb amputation was 98.5%.

“The 2-year results from the DETOUR2 study are encouraging and demonstrate PTAB using the Detour system offers good patency rates in long superficial femoral artery lesions,” commented Dr. Lyden in the Endologix press release. “As noted in the conclusion of the presentation, the 2-year data mimics those of surgical bypass without the need for general anesthesia, long length of stay, and high risk of complications. We look forward to continuing to study the Detour system.”

Dr. Lyden, who serves as one of the study’s principal investigators, is Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute in Cleveland, Ohio.

Last year, Dr. Lyden presented 1-year data from DETOUR2 at the VIVA Foundation’s VIVA22 conference.

On June 8, 2023, Endologix announced FDA approval of the Detour system for PTAB to treat patients with complex PAD. The Detour system is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 to 460 mm in length with chronic total occlusions (100-425 mm) or diffuse stenosis > 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The system percutaneously bypasses lesions in the superficial femoral artery by using stents routed through the femoral vein to restore blood flow to the leg. The Detour system is comprised of the Endocross device and Torus stent grafts, noted the company.