Endologix Detour System Approved to Treat Long Complex Femoropopliteal Lesions

June 8, 2023—Endologix LLC announced FDA approval for the Detour system to treat patients with complex peripheral arterial disease (PAD) via percutaneous transmural arterial bypass (PTAB).

Endologix advised that the Detour system is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100-425 mm) or diffuse stenosis > 70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The Detour system and any of its components are not for use in the coronary and cerebral vasculature, noted the indications for use in the company’s press release.

According to Endologix, PTAB with the Detour system offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral artery by using its Torus stents routed through the femoral vein to restore blood flow to the leg. This approach is particularly effective for patients with long lesions, patients who have already undergone failed endovascular procedures, or patients who may be suboptimal candidates for open surgical bypass, noted the company.

“We are delighted to receive FDA approval of the Detour system," said Matt Thompson, MD, President and CEO of Endologix, in the company’s press release. "PTAB therapy represents a significant step forward for patients with complex PAD. They have long needed a more effective and less invasive treatment option for long lesions of the SFA. We are proud to be pioneering this novel approach and continuing to innovate on behalf of patients. We look forward to launching this new therapy in the United States through a targeted market release in the coming weeks.”

In April 2021, Endologix announced it had completed the acquisition of PQ Bypass, Inc., bringing the Detour system as well as the Torus stent graft into the Endologix product pipeline.