PQ Bypass said yesterday that its Detour I trial met its primary safety and efficacy endpoints. The company’s trial is evaluating its fully percutaneous bypass treatment for patients with complex superficial femoral artery occlusions.
The Sunnyvale, Calif.-based company’s procedure is less invasive compared to traditional treatment options to revascularize arterial blockages in the leg. PQ Bypass touts its Detour procedure as being designed to match or exceed the durable patency associated with open surgical bypass.
The company’s procedure met safety and efficacy endpoints with its 6-month data from the Detour I single-arm trial: 3.4% of patients experienced a major adverse event, while nearly 85% of patients met primary patency.
“The data from this study strongly suggest that the PQ Detour procedure provides a viable option for revascularization via modular stent graft bypass, a much-needed treatment option for patients with long-segment occlusive disease,” Dr. Dierk Scheinert, of the University Hospital Leipzig in Germany, said in prepared remarks. “The clinical performance in severe lesions demonstrates the potential for this novel therapy for complex patients who are otherwise left without a durable endovascular option. The results warrant further evaluation as percutaneous bypass using the femoral vein as a conduit may prove to be an important step forward in the treatment of extremely long SFA occlusions.”
As part of the PQ Detour procedure, users guide a series of PQ Bypass stent grafts from the popliteal artery into the femoral vein and into the superficial femory artery. The result is an endograft bypass that delivers pulsatile flow and restores blood flow to the lower extremities.
“We are thrilled with the 6-month data from Detour I,” PQ Bypass president & CEO Peter Wehrly added. “We view the Detour procedure as a transformative step forward in how physicians treat long-segment SFA disease. We believe our percutaneous approach will demonstrate the durable patency outcomes previously only seen with open bypass surgery, and steer care away from costly intraluminal endovascular techniques that are arduous and lack sufficient durability.”