Endologix LLC announced the 12-month results from the DETOUR 2 clinical trial. DETOUR 2 was an Investigational Device Exemption (IDE) study, designed to evaluate safety and effectiveness of the DETOUR System for percutaneous bypass in the treatment of long-segment femoropopliteal disease. The DETOUR System uses the ENDOCROSS™ catheter and TORUS™ stent graft to perform a totally percutaneous femoro-popliteal bypass routed through the femoral vein.

The National Principal Investigators of DETOUR 2 were Sean Lyden MD, Chairman of the Department of Vascular Surgery at Cleveland Clinic's Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and Jihad Mustapha MD, FACC, FSCAI President and Chief Executive Officer and Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention. The 12-month results from the DETOUR 2 Study were presented during a plenary session at the 2022 Annual Meeting of the Society of Vascular Surgery by Dr. Lyden. The Detour 2 clinical trial enrolled 202 patients in the United States and Europe for the primary analyses.

This cohort represents a patient population with severe femoropopliteal artery disease. Ninety-six percent of the patients had chronic total occlusions (CTO), the mean lesion length was 327.14 mm with a CTO length of 217.31 mm, and 70.4% had severe calcification. The results presented are listed below: Primary patency was 72.1% (Kaplan-Meier Estimate) at 12-months The major adverse event rate was 7% at 30-days - The incidence of Deep Vein Thrombosis (DVT) of 2.5% and 4.1% at 30 days and 12 months, respectively - No pulmonary emboli occurred through 12-months.