Early Findings Presented for PQ Bypass’ Endovascular Femoropopliteal Artery Bypass Procedure
September 14, 2016—PQ Bypass, Inc., which is developing a fully percutaneous approach (the PQ Detour procedure) to femoropopliteal bypass surgery, announced that early results of a study using the PQ bypass system were presented by Piotr Szopiński, MD, at CIRSE 2016, the annual meeting of the Cardiovascular and Interventional Radiology Society of Europe annual meeting in Barcelona, Spain. Dr. Szopiński is Head of the Clinic of Vascular Surgery at the Institute of Hematology and Transfusion Medicine in Warsaw, Poland.
In the PQ Detour procedure, fluoroscopic guidance is used as a series of PQ stent grafts are deployed from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery (SFA) in a continuous, overlapping fashion through two independent anastomoses. The final result is a large-lumen, endograft bypass that delivers unobstructed, pulsatile flow from the SFA ostium to the popliteal artery.
The company advised that the PQ Bypass platform is not available for sale and is currently undergoing clinical trials. James Joye, DO, and Richard Heuser, MD, developed the underlying technology and technique used in the percutaneous PQ Detour procedure. Dr. Joye is from El Camino Hospital in Mountain View, California. Dr. Heuser is from St. Luke’s Hospital in Phoenix, Arizona.
As summarized in the CIRSE abstract, the endovascular femoropopliteal artery bypass study sought to evaluate the safety and effectiveness of the PQ bypass system in accessing the femoral vessels, delivering guidewires, and implanting stent grafts for a percutaneous femoropopliteal bypass.
In this multicenter, nonrandomized, single-arm study, patients were evaluated using computed tomography angiography and ultrasound examination. The PQ bypass system was used to place a guidewire from the proximal femoral artery into the femoral vein and back into the distal femoropopliteal artery, thus bypassing the lesion within the femoral artery. Stent grafts were deployed in a modular fashion over the guidewire from distal to proximal using the adjacent vein as a conduit. Follow-up was conducted at 3 and 6 months via arterial and venous ultrasound examinations.
To date, 45 patients (30 males; mean age, 62 years) have been treated in the study. Of these patients, 15 (33%) have undergone follow-up at 6 months. The mean lesion length was 23.9 ± 6.3 cm. One patient experienced an adverse event; the edge stenosis was treated after 6 months via atherectomy.
The investigators reported that the PQ bypass system successfully delivered guidewires and placed stent grafts and thus completed a percutaneous femoropopliteal bypass in 100% of the cases. Primary patency at 6 months was 93%. Both primary safety and effectiveness endpoints were met.
The study demonstrates that a percutaneous bypass of long lesions in the femoropopliteal artery can be successfully achieved using the PQ bypass system and the device provides a safe alternative to bypass surgery, concluded the investigators in the CIRSE abstract.
PQ Bypass advised that early results of the endovascular femoropopliteal artery bypass study will be presented by Dainis Krievins, MD, on November 1 at TCT 2016, the Transcatheter Cardiovascular Therapeutics meeting in Washington, DC.
In other company news, PQ Bypass announced that Peter Wehrly has assumed the role of President and Chief Executive Officer; Heather Simonsen has been named as Vice President of Global Marketing; and Christopher Owens has become a member of the company’s Board of Directors.