PQ Bypass
Transforming the Treatment of Long, Complex SFA Disease

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 18 million people in the United States suffer from PAD, a common circulatory problem in which narrowed or blocked arteries reduce blood flow to the limbs. The estimates suggest that anywhere from 12 to 20 percent of individuals over the age of 60 are living with PAD, with the most common condition being blockages of the Superficial Femoral Artery (SFA)/popliteal segment. Once PAD progresses to debilitating leg pain (claudication) or tissue loss, revascularization becomes imperative to mitigate ongoing deterioration and to prevent amputation. To date, open surgical femoropopliteal bypass remains the durability gold standard for treating long, complex 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.

This is where PQ Bypass, an innovative medical device company, takes center stage with its proprietary Detour System, which has been designated by the U.S. Food and Drug Administration as a Breakthrough Technology. The Detour System enables physicians to perform a fully percutaneous fem-pop bypass and is designed to mimic the durability of open fem-pop bypass surgery through a minimally invasive approach. “With our Detour System and procedure, our vision is to establish a new endovascular standard of care for long, complex SFA lesions,” states Richard Ferrari, Chairman of the Board and CEO, PQ Bypass. He further says, “We expect this technology to change the paradigm for complex SFA treatment in the way EVAR and TAVR changed the paradigm for aortic repair.”

The DETOUR System consists of two technologies: TORUS Stent Graft and the DETOUR Crossing Device.

With our Detour System and procedure, our vision is to establish a new endovascular standard of care for long, complex SFA lesions

These devices were specifically designed to perform a femoropopliteal bypass via two small punctures in the skin instead of open surgery and the procedure is designed to be performed on an outpatient basis. During the DETOUR procedure, a pathway is created by crossing from the superficial femoral artery (SFA) into the femoral vein and back into the arteryusing the DETOUR Crossing Device and a 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 goalof 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.

The Detour system is currently being studied in the US IDE DETOUR 2 Clinical Trial. “Patients suffering from this type of advanced, complex SFA disease need a minimally-invasive treatment option that moves the durability needle closer to open surgery,” says Heather Simonsen, President at PQ Bypass.

Established in 2009, PQ Bypass boasts a proficient and experienced team who has held senior positions at many reputed healthcare organizations. The company is now laser-focused on racing toward its regulatory milestones over the next year. “Our clinical program is advancing according to our expectations and we plan to submit our PMA to the FDA by the end of 2021,” concludes Simonsen.