Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration (FDA).
The Detour system, which earned FDA Breakthrough Device Designation, is a unique therapy that 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).
The PMA application includes the results of the DETOUR2 IDE study, which were presented at the 2022 Annual Meeting of the Society for Vascular Surgery (SVS; 15–18 June, Boston, USA). Sean Lyden, one of the study’s principal investigators presented results that included 12-month primary patency of 72.1% in SFA lesions with a mean length of 32.7cm. The trial demonstrated technical success of 100% in 202 patients, with a 30-day major adverse event rate of 7%.
“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,” said Matt Thompson, president, and chief executive officer of Endologix. “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.”