PQ Bypass wins CE Mark for trio of PAD tools

March 13, 2017 By Fink Densford Leave a Comment

PQ Bypass said today it won CE Mark approval for 3 devices designed to treat patients with superficial femoral artery lesions due to peripheral artery disease.

The Sunnyvale, Calif.-based company said it won clearance for its Torus stent graft system, PQ Snare and PQ crossing device, all used in the company’s Detour procedure.

“With an increased focus on value-based and patient-centered medicine, surgical advancements that minimize trauma to patients, reduce length of hospital stay and recovery times are critical global needs. CE Mark is an important milestone for PQ Bypass and we look forward to continuing our clinical studies, including an upcoming IDE study, with an eye toward FDA approval. Data presented at LINC 2017 demonstrated that the Detour procedure has clear potential as a viable change in how extremely long SFA occlusive disease is treated in the future,” CEO Peter Wehrly said in a prepared statement.

The PQ Detour procedure is a fully-percutaneous femoral-popliteal bypass procedure which uses fluoroscopic guidance to deploy Torus stent grafts from the popliteal artery into the femoral vein, and from the femoral vein into the superficial femoral artery through 2 independent anastomoses.

PQ Bypass’ Torus stent graft is an expanded polytetrafluoroethylene-covered self-expanding nitinol stent designed to improve blood flow in patients with symptomatic peripheral artery disease in superficial femoral artery de novo and restenotic TASC II C and D lesions.

“There is a great unmet need for a durable percutaneous option for these patients with extremely long blockages in the legs due to PAD. While other percutaneous approaches have been attempted, long-term success and patency have been difficult to achieve, resulting in limited options for these patients,” Dr. Sean Lyden of Cleveland Clinic’s Sydell and Arnold Miller Family Heart & Vascular Institute said in a prepared release.

The company said its CE Mark approval was based on data from the prospective, multi-center Detour I trial, which reported meeting primary safety and effectiveness endpoints at 6-months. Results from the trial were released in January.

“The PQ Detour procedure is a truly new and innovative approach to treating patients with extremely long SFA lesions. The initial safety and effectiveness of the Detour procedure, as shown in the Detour I trial, is very encouraging and the results clearly demonstrate the potential for this to become a key addition to the treatment armamentarium for patients with complex PAD,” Detour I study investigator Dr. Dainis Krievins of Riga, Latvia’s Institute of Research of Pauls Stradins Clinical University Hospital said in a press release.

Registration is Open for DeviceTalks Boston

Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.

REGISTER NOW

Medical device cybersecurity: It’s time to get real
Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough? Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One… […]
Can a lifetime guarantee boost value-based care?
Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries. The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes.… […]
Compounding Solutions launches new tie-layer resin
Compounding Solutions (Lewiston, Maine) recently announced that it has launched a new tie-layer resin for the medical device industry. ReZilok Rx is meant for the manufacturing of multilayer co-extruded medical films and catheter tubing, the company said in a February announcement. Compounding Solutions’ R&D team developed ReZilok Rx as a linear low-density polyethylene grafted with… […]
GI Dynamics touts results of U.K. study
GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients. The EndoBarrier device is a plastic gut sleeve designed… […]
Think Surgical, United Orthopedic join forces for global sales
Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system. Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with… […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts… […]
AxioMed receives CE Mark approval for Cervical Freedom
AxioMed has received CE Mark approval for its viscoelastic disc replacement device. The Cervical Freedom’s total disc replacement is now eligible for commercialization in the European, Asian, Latin American and Australian markets and where it has already been TGA approved. AxioMed’s Freedom Cervical disc responds to loading and moves in three dimensions like the human… […]
10 orthopedic products from AAOS 2019 you need to know
The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink. While the SVB Leerink analysts termed Stryker’s (NYSE:SYK) Mako platform “best-in-class,” robotically assisted orthopedic surgery is an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new… […]
Webinar: Here’s how you create better healthcare experiences through human-centered design
Wednesday, April 17, 2019 2 p.m. Eastern time / 11 a.m. Pacific time The greatest challenges in healthcare are at the human level. Diet, fitness, medication adherence and regular check-ups can all be influenced by our personal relationships. While today’s technology can impede these human-to-human interactions, following a human-centered approach gives organizations the power to… […]
Orthopaedic Implant Co. enters sports medicine market with new suture anchor
The Orthopaedic Implant Company (“OIC”) said it has launched a 5.5mm PEEK suture anchor system for orthopedic surgery. The OIC 5.5mm suture anchor accommodates up to three #2 sutures of any brand, resulting in an implant that offers flexibility, at a cost-effective price, according to the Reno, Nev.-based company. The anchors are made of biocompatible… […]
Oberd launches AI-assisted tech for gathering outcome data
Patient-reported outcomes vendor Oberd said it has launched software designed to reduce a patient’s time in completing outcomes surveys for orthopedic procedures. Patient-reported outcomes can help quantify the value of a healthcare provider’s services. Columbia, Mo.-based Oberd’s computer-adaptive test (CAT) software has been developed and validated for all of the outcomes surveys approved by the… […]