PQ Bypass Snagged CE Mark for Trio of Devices

Posted in Medical Device Business by amanda.pedersen on March 20, 2017

PQ Bypass has developed a trio of devices designed to help doctors perform a fully percutaneous femoral popliteal bypass in patients with extremely long lesions in their superficial femoral artery due to peripheral arterial disease. The new devices now have CE mark approval in Europe.

Amanda Pedersen

 

The PQ Stent Graft System is designed for flexibility and robust durability to help maintain an open lumen. The device is one of three that are used during the PQ Detour procedure.

 

PQ Bypass Inc. now has CE mark for a trio of devices designed to enable a new procedure, dubbed the PQ Detour procedure, which the company specifically developed to help physicians treat the most complex cases of peripheral arterial disease (PAD).

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The concept of the new procedure was born out of frustration. Jim Joye, an interventional cardiologist and one of the company’s co-founders, was frustrated that there was not a good endovascular treatment option for patients with tough, elongated lesions.

Current endovascular procedures simply didn’t yield durable results, said Peter Wehrly, president and CEO of PQ Bypass. Open bypass treatment options tend to work fairly well, Wehrly said, but the surgery is tough on the patients. Most patients who have the open procedure are in the hospital at least six days, and between 25% and 30% of them are re-admitted to the hospital within 30 days due to complications.

With the Detour procedure, the same type of patient usually goes home the following day after surgery, and have a relatively shorter recovery period, Wehrly said.

“If my mother or father needed this procedure versus an open procedure, there’s no question how that would work in my mind,” Wehrly told Qmed.

The PQ Detour procedure is specifically designed for treating patients with lesions that are defined as TransAtlantic InterSociety (TASC) II C or D total occlusions.

“These are the toughest of the tough,” Wehrly said.

The procedure is designed to match or exceed the durable patency associated with open surgical bypass, but achieve those results with a less invasive endovascular procedure.

The procedure uses the Torus stent graft system, which is an expanded polytetrafluoroethylene (ePTFE) covered self-expanding nitinol stent intended to improve blood flow. The PQ Snare and PQ Crossing devices are used to retrieve and manipulate atraumatic foreign bodies in the distal peripheral vasculature, and to support the placement and positioning of guidewires in the peripheral vasculature.

CE mark approval of the devices was based on data collected in DETOUR I, a prospective, multi-center, core-lab reviewed, single-arm trial designed to evaluate the safety and efficacy of the procedure with TASC II C and D total occlusions in the femoral-popliteal anatomy. The study met both its primary safety and effectiveness endpoints at six months.

“The PQ Detour procedure is a truly new and innovative approach to treating patients with extremely long SFA lesions,” said Dainis Krievins, professor of vascular surgery at the University of Latvia, director of the Institute of Research of Pauls Stradins Clinical University Hospital in Rigna, Latvia, and investigator in the DETOUR I study.

Krievins said the initial safety and effectiveness of the procedure, as shown in the trial, is encouraging, and demonstrate the potential for the procedure to become a “key addition to the treatment armamentarium for patients with complex PAD.”

Wehrly said the company has already met with FDA to discuss an upcoming submission for an investigational device exemption study. If all goes well, that study could begin enrolling patients sometime in the next 18 months, he said.

Amanda Pedersen is Qmed's news editor. Contact her at amanda.pedersen@ubm.com.