Endologix Releases 24-Month DETOUR2 Study Data

Endologix has announced the 24-month results from its DETOUR2 study. Percutaneous transmural arterial bypass (PTAB) using the company’s DETOUR system earned FDA PMA approval on June 7.
 
The system presents a unique approach to treating complex peripheral arterial disease (PAD) so physicians can percutaneously bypass lesions in the superficial femoral artery by using stents routed through the femoral vein to restore the leg’s blood flow. DETOUR is comprised of the ENDOCROSS device and TORUS stent grafts.
 

The study enrolled 202 patients in the U.S. and Europe. The 24-month results were presented at 2023 Annual Meeting of the Society of Vascular Surgery by one of the study’s principal investigators, Dr. Sean Lyden, Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.
 
96% of patients had chronic total occlusions, with average lesion length of 32.7 cm. 100% of treated patients achieved technical success and the primary safety endpoint was exceeded with a 30-day MAE rate of 7%.
 
Freedom from symptomatic DVT was 96.5% at 24 months, and freedom from major lower limb amputation was 98.5%.
 
“The two-year results from the DETOUR2 Study are encouraging and demonstrate PTAB using the DETOUR System offers good patency rates in long SFA lesions. As noted in the conclusion of the presentation, the two-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 told the press.
 
“We are delighted to present the two-year results of the DETOUR2 Study which investigates the use of the PTAB therapy in patients with very long SFA lesions,” added Professor Matt Thompson, MD, president and CEO of Endologix. “The results suggest that the DETOUR System offers a viable approach in patients where open surgery is the currently recommended treatment. We are excited to see more patients benefit from this unique approach to the treatment of complex PAD.”