Written by Kymberlie McNicholas, Founder of The Way to My Heart
“Unlike open fem-pop bypass surgery, which usually requires a 3-5 day stay in the hospital, along with a recovery and rehabilitation period, percutaneous fem-pop bypass is performed on an outpatient basis, patients usually return home the same day, and are able to resume their day-to-day activities within a few days,” explains PQ Bypass President Heather Simonsen
As part of our ongoing Vascular Innovation Series in conjunction with The Way to My Heart, Emmy Award-winning Journalist Kym McNicholas interviews PQ Bypass President Heather Simonsen.
The gold standard for treating blocked arteries in the legs is surgical bypass. While it is a durable approach, it also presents a low risk of serious complications including cardiovascular events, wound complications, graft infections, and in rare cases even death. It also requires a multiple day hospital stay and a long recovery for patients, anywhere between 6-8 weeks. Endovascular procedures, while not as durable in most cases, can be performed in an outpatient setting so that patients are home same day.
What if the two approaches could be combined? That’s what the PQ Bypass Detour System does. It creates a bypass percutaneously, meaning it redirects blood flow around a blockage from the Superficial Femoral Artery (SFA) ostium to the popliteal artery through the vein.
The easiest analogy is a traffic jam. Imagine there’s gridlock traffic on the freeway due to an accident blocking southbound lanes. Authorities move the center barrier adding lanes from the less trafficked northbound side of the freeway to restore traffic flow. The flow of cars traveling north is largely uninterrupted but the cars traveling south now have a way around the blockage. That’s PQ Bypass Detour System in a nutshell – they apply this theory to the human superhighway – our arteries and veins.
Heather Simonsen, President of PQ Bypass explains the impact of this technology on the treatment of Peripheral Artery Disease.
What is the story behind the technology? Where did it originate?
Officially launched in 2004, PQ Bypass was one of the first companies to come out of the Fogarty Institute for Innovation, from an idea developed by Dr. Jim Joye, an interventional cardiologist, medical device pioneer, and world-renowned expert in Peripheral Arterial Disease at El Camino Hospital in Mountain View, CA.
In his medical practice, Dr. Joye had seen numerous patients with long, tortuous occlusions in their peripheral vasculature—mostly between their groin and knee in the SFA, with some extending the entire length of their leg—and set about trying to find a minimally-invasive solution for these long, complex lesions that, historically, were only treated by open fem-pop bypass surgery.
What need does it address?
Femoropopliteal atherosclerotic lesions constitute the most common cause of symptomatic peripheral artery disease (PAD). Up to 50% of patients with claudication have a superficial femoral artery (SFA) occlusion. Although long-segment femoropopliteal PAD (>200mm) is common, this population is excluded from virtually all device trials. The Trans-Atlantic Inter-Society Consensus (TASC) II recommendations suggest bypass surgery for the treatment of extensive atherosclerotic disease with long lesions (TASC D), however, patients with TASC D lesions commonly suffer from significant comorbid medical conditions and are therefore at increased risk for adverse events when treated with bypass surgery.
PQ Bypass’ Detour procedure is the first endovascular fem-pop (femoral popliteal) bypass procedure and is differentiated from other endovascular procedures that are intended to open shorter blockages. It is also differentiated from open fem-pop bypass surgery in that it is done in an outpatient setting via minimally invasive instrumentation, while open fem-pop bypass surgery is an invasive procedure, is only done on an inpatient basis, and typically requires a 3-5 day stay in the hospital. During the Detour procedure, physicians use PQ Bypass’s proprietary devices and stent-grafts to go around the occlusive disease in the artery and create the bypass. This is done by creating an arteriovenous pathway from the SFA into the femoral vein and back into the artery, then placing a series of overlapping stent-grafts—usually two or three—to create the bypass which runs from the SFA, through a portion of the femoral vein, and back into the popliteal artery below the blockage. The bypass redirects the oxygen-rich blood through the stent-graft bypass around the occlusion so it can reach the lower leg and foot.
What is the potential for patient impact?
The goal of the percutaneous fem-pop bypass is to provide a minimally invasive, outpatient treatment option for patients with long, complex SFA disease. Unlike open fem-pop bypass surgery, which usually requires a 3-5 day stay in the hospital, along with a recovery and rehabilitation period, percutaneous fem-pop bypass is performed on an outpatient basis, patients usually return home the same day, and are able to resume their day-to-day activities within a few days.
Where is the technology in development and what is next for the company?
PQ Bypass is currently sponsoring the DETOUR2 Continued Access Trial in the United States. The DETOUR2 Pivotal Trial completed enrollment in 2020, and we are currently gathering follow up data, which we will submit to the FDA. If the FDA approves the technology, it will then be available widely in the United States. In the meantime, if a patient may be a candidate for the Detour percutaneous fem-pop bypass procedure, they may contact
The FDA granted the Breakthrough Device Designation for the Detour System for Percutaneous Fem-Pop Bypass. This designation is a significant achievement and validation of both the complexity of the disease state and the potential of the Detour System as a first-of-its-kind device to change the paradigm for complex SFA treatment in the way EVAR and TAVR changed the paradigm for aortic repair. Under the program, the FDA will provide PQ Bypass with priority review and interactive communication regarding device development and clinical trial protocols, during the premarket review process.
How can patients or advocates get involved?
We are starting our continued access program in 2021. Information about the PQ Bypass system is on our website. It’s important, however, that patients discuss all options available with their healthcare provider.
This interview was produced by The Way To My Heart in partnership with Vascular Cures. Neither The Way To My Heart nor Vascular Cures endorse any specific products, entrepreneurs, companies, organizations, drug or device trials, and/or healthcare professionals, including diagnosis or treatment programs. The information, advice, and views shared in this interview are that of the individual speakers and are offered for educational and informational purposes only.
This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Don’t act on any information provided in this interview without the explicit consent of your own healthcare provider who knows your situation best.
The safety and efficacy of the investigational use of the product discussed by Emory University’s Dr. Arshed Quyyumi has not been determined. There is no guarantee that the investigational use discussed will be filed with and/or approved for marketing by a regulatory agency.
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