PQ Bypass touted 12-month data today from a trial evaluating its Detour percutaneous femoropopliteal bypass system.
Results from the Detour I trial showed “promising 12-month durability” for patients with extremely long blockages in the superficial femoral artery, the company reported.
The study included lesions that were longer and more complex than typically seen in SFA trials: the average lesion length was 37 cm, PQ Bypass said.
“The lesions treated in Detour I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dr. Dainis Krieviņš, vascular surgeon & director of the Institute of Research at Pauls Stradins Clinical University Hospital. “Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average Detour lesion and fail approximately 40% of the time by the 12-month milestone. This truly highlights the need for the minimally invasive Detour procedure for long, complex SFA lesions.”
PQ Bypass’ percutaneous femoropopliteal bypass procedure uses the company’s stent grafts to make a path that sends blood around the blocked part of the artery, restoring blood flow to a patient’s lower leg and foot.
The company’s Detour I trial enrolled 77 patients and treated 81 lesions. Primary patency at 12 months in all lesions was 73%, while primary-assisted patency was 80%. Secondary patency was met in 94% of the study’s participants.
PQ Bypass also noted that the trial had 100% freedom of amputation, 99% freedom from acute limb ischemia and Rutherford improvement of greater than or equal to two classes in 90% of patients.
“These results represent exciting promise for patients with long, complex SFA lesions, a growing, yet severely underserved population,” Heather Simonsen, VP of global therapy development, said. “By routing blood around the disease, rather than forcing a way through it, the Detour System is designed to treat extremely long lesions that are not well-addressed by current endovascular devices.”
