Endologix DETOUR 2 Clinical Trial’s 12-Month Data Presented

June 23, 2022—Endologix LLC announced 12-month results from the DETOUR 2 clinical trial, which is a prospective, single-arm, international, multicenter evaluation of the company’s Detour system.

The investigational device exemption study was 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 femoropopliteal bypass routed through the femoral vein.

The 12-month results from the DETOUR 2 study were presented by Sean Lyden, MD, during a plenary session at the Society for Vascular Surgery’s (SVS) 2022 Vascular Annual Meeting held June 15-18 in Boston, Massachusetts.

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. Of these patients, 96% 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 company outlined the results presented at SVS as follows:

• Primary patency of 72.1% (Kaplan-Meier estimate) at 12 months
• Major adverse event rate of 7% at 30 days
• Incidence of deep vein thrombosis of 2.5% at 30 days and 4.1% at 12 months
• No pulmonary emboli through 12 months

“This system has potential to introduce a novel, minimally invasive alternative for patients in need of a femoropopliteal bypass,” commented Dr. Lyden in the Endologix press release. “The low complications, coupled with the 72% primary patency in these long lesions, provide positive evidence for the feasibility of this new technology in a difficult clinical setting.”

Dr. Lyden and Jihad Mustapha, MD, are the National Principal Investigators of DETOUR 2. Dr. Lyden is Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute in Cleveland, Ohio. Dr. Mustapha is President and Chief Executive Officer and Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, Michigan.