PQ Bypass Reports Data on the Detour System for Percutaneous Treatment of Long-Segment Femoropopliteal Artery Disease
September 12, 2017—PQ Bypass announced that a subset analysis from the DETOUR I clinical trial investigated the safety and effectiveness results of the company's Detour System for treating long-segment (> 25 cm) blockages in the femoropopliteal artery. The subset analysis evaluated percutaneous treatment of blockages with lengths of 25 cm to 45 cm (mean, 33.8 cm). The data were presented by Sean Lyden, MD, during a late-breaking clinical trial session at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada.
In the company's press release, Dr. Lyden commented, “Patients with long-segment femoropopliteal blockages are in need of advanced therapeutic alternatives to existing treatments. While endovascular revascularization is effective in shorter lesions, its durability in longer segment blockages has not matched that of open surgery. Fully percutaneous bypass is designed to combine the durability advantages of surgical bypass with the minimally invasive advantages of a percutaneous procedure. The outcomes we are seeing in the DETOUR I trial indicate that a fully percutaneous bypass procedure has potential to fill this gap in treatment options.”
According to the company, the 6-month outcomes from 50 patients demonstrated the Detour system’s ability to successfully treat these long blockages without significant impact on venous health and low rates of major adverse events (MAEs; defined as death, target vessel revascularization [TVR], or amputation at 30 days).
The primary safety endpoint (the MAE rate) was 2% with no deaths or amputations and one TVR. One patient underwent TVR graft disassociation, which resulted in acute limb ischemia before discharge, and the patient was treated successfully with an additional Detour stent graft. Additionally, primary patency was 88.9% at 6 months with optimal placement, and overall primary patency was 76.9%.
Dr. Lyden reported successful delivery of devices to the identified area and removal of the delivery system in 100% (53/53) of lesions. There was improvement in Rutherford class of at least two grades in 92% (45/49) of patients (this excludes a patient who died from ischemic stroke before 6-month follow-up). There was also significant improvement in ankle-brachial index from 0.64 ± 0.17 to 0.92 ± 0.14 (P < .0001). Finally, there was no impact on venous function and no device-related deep vein thrombosis in treated vessels.
According to the company, the Detour procedure of percutaneous femoropopliteal bypass to treat long-segment blockages in the femoropopliteal artery creates a pathway around a lesion by placing stent grafts that cross from the superficial femoral artery into the femoral vein and back into the artery. The new path through the stent grafts redirects oxygen-rich blood around the blockage and restores blood flow to the lower leg and foot of the patient.
The procedure utilizes PQ Bypass’ Detour system technologies: the Torus stent graft, Detour crossing device, and Detour snare. In March 2017, PQ Bypass received European CE Mark approval for the three devices that are included in the Detour system.
PQ Bypass advised that DETOUR II pivotal trial is expected to begin by the end of 2017 to support regulatory approval for the Detour system, which is not available for sale in the United States.