Irvine, California–Endologix picked up premarket approval on June 7 for its Detour system to treat long, complex superficial femoropopliteal lesions.
The DETOUR2 study evaluated the system’s performance in percutaneous transmural arterial bypass (PTAB). This approach aims to treat complex peripheral arterial disease (PAD) by percutaneously bypassing lesions in the superficial femoral artery. It uses stents routed through the femoral vein to restore blood flow to the leg.
Endologix’s EndoCross device and Torus stent grafts comprise the Detour system.
Principal investigator Dr. Sean Lyden presented two-year results from the study at the 2023 Annual Meeting of the Society of Vascular Surgery. Lyden serves as chair of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute.
“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,” Lyden said. “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.”
Results from the Endologix study
According to a news release, DETOUR2 enrolled 202 patients in the U.S. and Europe. In the patient population, 96% of enrolled patients had chronic total occlusions. The mean lesion length measured 32.7 cm.
Data presented included technical success achieved in 100% of treated patients. The study surpassed its primary safety endpoint with a 30-day major adverse event rate of 7%. Freedom from clinically driven target lesion revascularization at 24 months came in at 76.7%. Secondary patency totaled a rate of 82.3%.
Endologix reported freedom from symptomatic deep vein thrombosis at 24 months. Freedom from major lower limb amputation registered at 98.5% at 24 months.
“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,” said Dr. Matt Thompson, 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.”
