Endologix Detour System Submitted to FDA for Premarket Approval

October 10, 2022—Endologix LLC announced the submission of a premarket approval (PMA) application seeking FDA approval for the company’s Detour system, which allows the creation of a fully percutaneous femoropopliteal bypass that is routed through the femoral vein.

The Detour system uses the EndoCross device and Torus stent graft to treat patients with moderate to severe peripheral arterial disease with long blockages of the superficial femoral artery (SFA).

In June 2020, the Detour system was granted FDA Breakthrough Device designation.

According to the company, the PMA application includes the results of the DETOUR 2 investigational device exemption study, which were presented by Sean Lyden, MD, during a plenary session at SVS 2022, the Society for Vascular Surgery’s Vascular Annual Meeting held June 15-18 in Boston, Massachusetts. Dr. Lyden is one of the study’s principal investigators.

The presented results included 12-month primary patency of 72.1% in SFA lesions with a mean length of 32.7 cm. The trial demonstrated technical success of 100% in 202 patients with a 30-day major adverse event rate of 7%.

Matt Thompson, MD, President, and CEO of Endologix, commented in the company’s press release, “This submission is a significant milestone in our mission to expand our therapeutic products into the large peripheral vascular market opportunity. Patients with long SFA blockages have compromised treatment options at present due to high rates of failure with conventional endovascular techniques and the morbidity associated with open femoropopliteal bypass surgical procedures.”

Dr. Thompson continued, “Once approved, offering a fully percutaneous femoropopliteal bypass, will provide a disruptive, innovative therapy to physicians for the treatment of long-segment SFA disease and expand the treatment options available for these patients.”