PQ Bypass has received a CE mark for a suite of devices for treating patients with long superficial femoral artery blockages. The PQ devices are designed to enable surgeons to perform minimally invasive procedures on patients whose arteries are blocked by segments of plaque too long to treat with standard endovascular revascularization.
European officials have awarded the CE mark to the three devices that make up PQ’s solution to this problem: Torus Stent Graft System, PQ Snare and PQ Crossing Device. Together, the devices facilitate the Detour procedure, a surgical technique PQ developed.
In January, a single-arm trial of 59 patients linked the procedure and its underlying technologies to a six-month primary patency rate of 84.7%. The patency rate shows the proportion of vessels that remained open. And, with the rate coming in 15% above the study performance goal of 70%, PQ reported the trial met its primary efficacy endpoint. The 30-day major adverse event rate of 3.4% was also enough for the study to hit its primary safety goal.
PQ used those data to secure the CE mark. And, with that clearance in the bag, the West Coast device developer has shifted its attention to readouts from an investigational device exemption (IDE) study and other tests that could tee it up to being its technologies to market in the U.S.
“CE mark is an important milestone for PQ Bypass and we look forward to continuing our clinical studies, including an upcoming IDE study, with an eye toward FDA approval,” PQ CEO Peter Wehrly said in a statement. PQ raised $10 million last year to fund testing of its devices and procedure.
The Detour procedure is built around Torus, an expanded polytetrafluoroethylene covered self-expanding nitinol stent that is deployed from the popliteal artery to the femoral vein using fluoroscopic guidance. Once in the femoral vein, the series of stent grafts are moved into the superficial femoral artery to create a bypass that facilitates blood flow to the lower extremities. The other two devices—PQ Snare and PQ Crossing Device—are used to retrieve foreign bodies and place guidewires.