Company Expands Vascular Reach to Treat Unmet Needs of Both AAA and PAD Patients IRVINE, Calif.—(BUSINESS WIRE)—April 13, 2021—Endologix LLC, a leader in the treatment of vascular disease, today announced it has completed the acquisition of PQ Bypass, Inc., a privately held medical technology company pioneering a first-of-its-kind technology that addresses an unmet need for new […]
Tag: PQ Bypass
PQ Bypass Releases Positive 24-Month Data from the DETOUR1 Clinical Trial for Percutaneous Femoropopliteal Bypass at VIVA 2020
Promising long-term safety and effectiveness results from PAD population with extremely complex SFA disease MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc, a medical device pioneer bringing new advancements to the treatment of complex peripheral artery disease (PAD), announces promising long-term safety and effectiveness results from 24-month follow-up data from the DETOUR1 Clinical Study, including a 79% primary […]
PQ Bypass Completes Enrollment in DETOUR2 Percutaneous Femoral-Popliteal Bypass Pivotal Study for Patients With Complex Peripheral Arterial Disease
FDA-designated Breakthrough Device now one step closer to PMA submission MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, an innovative medical device company pioneering advancements in the treatment of complex peripheral artery disease (PAD), announces enrollment of the final subject in the company’s flagship IDE, the DETOUR2 clinical trial. This important milestone occurs only a month after the Detour […]
PQ Bypass Receives FDA “Breakthrough Device Designation” for the World’s First Fully Percutaneous Femoral-Popliteal Bypass Device
Designation Expedites Physician Access to Device for Patients with Extremely Long and Complex SFA Lesions MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Detour […]
PQ Bypass Announces 100th Patient in Clinical Study to Evaluate Percutaneous Fem-Pop Bypass for Extremely Long Blockages in Leg Arteries
DETOUR Procedure Designed to Move Treatment from Inpatient to Outpatient Setting MILPITAS, Calif.–(BUSINESS WIRE)–Silicon Valley-based medical device company PQ Bypass announced today the 100th patient in the DETOUR2 Clinical Trial, which evaluates the safety and effectiveness of the minimally invasive DETOUR procedure for percutaneous femoropopliteal bypass. The case was performed by Dr. Jonathan Bowman at […]
CMS Approves Coverage for PQ Bypass TORUS 2 IDE Trial
Latest accomplishment reached by Silicon Valley med-tech company currently enrolling two IDE studies MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device company bringing new advancements to the treatment of peripheral artery disease (PAD), announced today that it has received approval for coverage from the Centers for Medicare and Medicaid Services (CMS) for the Investigational Device […]
CORRECTING and REPLACING PHOTO PQ Bypass Initiates Pivotal Study of Next-Generation Advancement in Stent Graft Technology for Treatment of Patients with Peripheral Artery Disease
MILPITAS, Calif.–(BUSINESS WIRE)–Please replace the photo with the accompanying corrected photo. The release reads: PQ Bypass, Inc., a clinical-stage medical device company, today announced it has enrolled the first patient in its TORUS 2 multi-center clinical trial of its self-expanding TORUS® stent graft system, a novel technology designed for the treatment of peripheral artery disease […]
PQ Bypass Announces Unconditional IDE Approval From U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2)
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years. MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed for the treatment of peripheral […]
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 trials: […]
PQ Bypass Announces First Patient Treated in Landmark DETOUR II Trial Evaluating New Treatment Approach for Clogged Leg Arteries
SUNNYVALE, Calif.–(BUSINESS WIRE)– PQ Bypass, a clinical-stage medical technology company that has developed the DETOUR procedure, a novel treatment for long (>15 cm) superficial femoral artery (SFA) blockages, announced enrollment of the first patients in the pivotal DETOUR II Trial in the United States. The trial is a prospective, single-arm clinical trial designed to evaluate the […]