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Detour 2 is designed to evaluate safety and effectiveness of the DETOUR System for percutaneous bypass in the treatment of long-segment femoropopliteal disease.
June 27, 2022
2 Min Read
Image courtesy of Rancz Andrei / Alamy Stock Photo
Endologix, a private company, that provides interventional treatments for vascular disease, announced the 12-month results from the DETOUR 2 clinical trial. DETOUR 2 was an 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 femoropopliteal bypass routed through the femoral vein.
The clinical trial enrolled 202 patients with severe femoropopliteal artery disease in the US and Europe for the primary analyses. 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.
Results of the study indicated that primary patency was 72.1% at 12 months, the major adverse event rate was 7% at 30 days, and the incidence of deep vein thrombosis was 2.5% and 4.1% at 30 days and 12 months, respectively. No pulmonary emboli occurred through 12 months.
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 CEO 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.
“This system has potential to introduce a novel, minimally invasive alternative for patients in need of a femoropopliteal bypass. 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,” said Lyden, in a prepared statement.
Matt Thompson, MD, President and CEO of Endologix remarked in a company press release that the PMA application for the Detour System, designated as a Breakthrough Device by FDA, will be submitted to FDA “shortly.”
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