In this week’s DeviceTalks Weekly Podcast, Liane Teplitsky, vice president and general manager of worldwide robotics at Zimmer Biomet, shares her excitement for the burgeoning data business emerging in orthopedics. Teplitsky, an engineer who built her medtech career in cardiac R&D and sales at St. Jude and Abbott, walks us through the interconnected offerings of […]
PQ Bypass
Endologix acquires PQ Bypass
Endologix today announced that it has completed its acquisition of PQ Bypass for an undisclosed amount. PQ Bypass makes the Detour platform that is designed for percutaneous femoral-popliteal bypass — providing a large lumen, endograft bypass to treat abdominal aortic aneurysm. FDA has designated Detour as a breakthrough device. The Detour System has the company’s […]
FDA OKs PQ Bypass trial of Torus peripheral stent graft
PQ Bypass said today that it won full FDA approval of its investigational device exemption trial for the Torus stent graft for treating peripheral artery disease. The Torus stent graft is designed to treat PAD in the superficial femoral artery by aiding in halting the progression of the disease, rather than solely treat the symptoms, […]
PQ Bypass raises $60m
PQ Bypass said today that it raised $60 million in an equity round of financing to help support its technology intended for treating patients with peripheral artery disease. The round was led by Deerfield Management and joined by existing investors including Seroba Life Sciences and MedTech Venture Partners, the Sunnyvale, Calif.-based company said. “With this funding […]
PQ Bypass touts 1-year Detour study data
PQ Bypass touted 12-month data today from a trial evaluating its Detour percutaneous femoropopliteal bypass system. Results from the Detour I trial showed “promising 12-month durability” for patients with extremely long blockages in the superficial femoral artery, the company reported. The study included lesions that were longer and more complex than typically seen in SFA […]
PQ Bypass wins IDE nod for Detour percutaneous femoropopliteal bypass study
PQ Bypass said today it won FDA investigational device exemption approval to launch a pivotal clinical trial of its Detour percutaneous femoropopliteal bypass system designed to treat patients with peripheral artery disease. The company’s Detour II clinical trial will look to enroll up to 292 patients with lower limb ischemia due to long blockages over 15 […]
PQ Bypass touts subset analysis data from Detour system trial
PQ Bypass today released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days. The data was presented today at the Vascular InterVentional Advances conference, the Sunnyvale, Calif.-based […]
PQ Bypass wins CE Mark for trio of PAD tools
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 […]
PQ Bypass study meets safety, efficacy endpoints
PQ Bypass said yesterday that its Detour I trial met its primary safety and efficacy endpoints. The company’s trial is evaluating its fully percutaneous bypass treatment for patients with complex superficial femoral artery occlusions. The Sunnyvale, Calif.-based company’s procedure is less invasive compared to traditional treatment options to revascularize arterial blockages in the leg. PQ […]