Endologix announced today that 12-month results from a trial of its Detour system demonstrated a low rate of complications.
Irvine, California-based Endologix’s Detour 2 FDA investigational device exemption (IDE) study was designed to evaluate the safety and effectiveness of the Detour system for percutaneous bypass in the treatment of long-segment femoropopliteal disease.
Detour uses the EndoCross catheter and Torus stent graft to perform a totally percutaneous femoro-popliteal bypass routed through the femoral vein.
According to a news release, Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute Chair of the Dept. of Vascular Surgery Dr. Sean Lyden, along with President, CEO and Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention Dr. Jihad Mustapha, were national principal investigators.
Lyden presented 12-month results from Detour 2 during a plenary session at the 2022 Annual Meeting of the Society of Vascular Surgery.
Detour 2 enrolled 202 patients in the U.S. and Europe with the cohort representing a patient population with severe femoropopliteal artery disease. Endologix said 96% 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.
Primary patency registered at 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) came in at 2.5% and 4.1% at 30 days and 12 months, respectively and there were no pulmonary emboli through 12 months.
Lyden said the Detour system has the potential to “introduce a novel, minimally invasive alternative for patients in need of a femoropopliteal bypass,” with low complications and 72% primary patency representing positive evidence for its feasibility.
“The Detour 2 study is an important step forward in a new endovascular treatment to address an area of a challenging clinical need for patients. The PMA application for the Detour system, designated as a breakthrough device by the FDA, will be submitted to the U.S. FDA shortly,” Endologix President and CEO Dr. Matt Thompson said in the release. “We are excited to be taking a step towards expanding treatment options in the femoropopliteal segment so that vascular surgeons can offer their patients this disruptive technology. Additionally, this trial is an important milestone as we continue to transform Endologix and expand our interventional vascular portfolio.”