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November 7, 2020

24-Month Outcomes Presented for PQ Bypass Detour Device

November 7, 2020—The Detour system (PQ Bypass) for percutaneous femoropopliteal bypass was evaluated for safety and effectiveness in the DETOUR 1 trial. The Detour procedure uses the PQ Bypass crossing device and a series of specially designed Torus stent grafts (PQ Bypass) to route blood flow around severe lesions caused by complex peripheral artery disease found in the superficial femoral artery (SFA). The procedure uses the femoral vein as a pathway for a Torus stent graft conduit and travels from the artery to the vein and back into the artery.

The 24-month DETOUR 1 data were presented by Ehrin Armstrong, MD, in a late-breaking clinical trial session at VIVA 2020, the Vascular InterVentional Advances annual meeting held as a virtual congress November 6-8, 2020.

VIVA 2020 announced that the trial enrolled an extremely complex patient cohort. The average lesion length was 371 mm; 96% of lesions had a confirmed chronic total occlusion, and 80% had evidence of moderate to severe calcification.

At 12 and 24 months postprocedure, the study reported primary patency rates of 81% at 12 months and 79% at 24 months. The rates of freedom from major adverse events were 83.7% and 82.1% at 12 and 24 months, respectively.

“The DETOUR I trial confirms the long-term efficacy and safety of endovascular bypass for the treatment of very long, complex femoropopliteal lesions,” commented Dr. Armstrong to Endovascular Today. “Prior clinical trials have specifically excluded the types of lesions treated in DETOUR 1, precisely because of the decreased patency rates observed when treating very long lesions. The results of DETOUR 1 suggest that percutaneous femoropopliteal bypass could be a game-changer for the treatment of patients with otherwise limited options.”

Dr. Armstrong further noted, “Based on these initial data and the ongoing DETOUR 2 trial, the FDA has recently granted percutaneous femoropopliteal bypass a breakthrough device designation.”

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