PQ Bypass
Reimagining Long-Segment Peripheral Artery Treatment

The ideal endovascular treatment for long-segment superficial femoral artery (SFA) disease continues to be the one of the most debated topics in the PAD market. While several different endovascular approaches have safely demonstrated reasonable effectiveness in lesions up to 15 cm in length, these same approaches, when applied to long, occlusive SFA disease (TransAtlantic Inter-Society Consensus C and D), have not demonstrated satisfying rates of long-term patency. To date, surgical femoropopliteal bypass remains the durability gold standard for treatment of long, occlusive SFA disease; however, this is not without a cost. Despite high overall patency, femoropopliteal bypass surgery is associated with a number of complications including lower extremity lymphedema, wound infection, graft occlusion, respiratory failure, acute kidney injury, stroke, and cardiovascular events, contributing to a 30-day morbidity rate of 37 percent.

To address these challenges, two world-renowned cardiologists and innovators with expertise in peripheral artery disease, Dr James Joye from El Camino Hospital in Mountain View, California, and Dr Richard Heuser from St. Luke’s Hospital in Phoenix, Arizona, developed a potentially safe, effective, minimally-invasive solution to treat long-segment peripheral artery blockages. This served as the foundation of PQ Bypass, Inc., which was launched in 2009. “Our goal is to combine the durability benefits of open surgery with the minimally-invasive benefits of an endovascular approach,” says Heather Simonsen, Senior Vice President and General Manager at PQ Bypass, Inc, “and ultimately expand the treatment options available for patients and the physicians who treat advanced SFA disease.”

The company’s flagship DETOUR System is a novel, investigational approach to fully-percutaneous femoropopliteal bypass. This newly developed procedure is enabled through the DETOUR System, which consists of three technologies: TORUS Stent Graft, the DETOUR Crossing Device and DETOUR Snare.

Our goal is to combine the durability benefits of open surgery with the minimally-invasive benefits of an endovascular approach

These devices were specifically designed to perform a femoropopliteal bypass via two small punctures in the skin rather than via open surgery.

During the DETOUR procedure, a pathway is created by crossing from the superficial femoral artery (SFA) into the femoral vein and back into the artery using the DETOUR Crossing Device and Snare. This pathway allows two or three Torus stent grafts (PQ Bypass, Inc.) to be deployed in overlapping fashion from the proximal popliteal artery, to and through the femoral vein, and back into the proximal SFA. The stent graft bypass redirects the oxygen-rich blood around the blockage and restores blood flow to the lower leg and foot of the patient. The restoration of blood flow has the goal of pain reduction and improvement of patient mobility.

Similar to other endovascular procedures, the DETOUR procedure has the potential to provide long-term durability while minimizing trauma to the body, hospital stays, and rehabilitation times. “We received CE Mark based on our DETOUR-1 clinical trial,” said Simonsen “and, based on the outcomes of that trial, we initiated the investigational device exemption (IDE) DETOUR-2 clinical trial, which is ongoing.” In addition, the TORUS Stent Graft System is under investigation in Europe for standard intra-arterial placement.

Run by recognized leaders in the medical device industry who have held senior positions at companies such as Abbott and Johnson & Johnson, PQ Bypass quickly achieved recognition in the cardiology market. In August 2017, the company was recognized by Frost & Sullivan with the 2017 European PAD Interventions Technology Innovation Award for the DETOUR procedure.

As PQ Bypass continues to grow and expand, it is striving to change how long-segment peripheral arterial disease is treated. “The company is on the path to making a difference,” says Simonsen, adding that the company’s focus for the next 12-18 months is on completing enrollment in the global program and research in the U.S. and Europe.