Tag: TAVR

CMS Makes Progress but Continues to Limit Life-Saving Access for Heart Valve Disease Patients

WASHINGTON, March 27, 2019 /PRNewswire/ — Alliance for Aging Research, Association of Black Cardiologists, Heart Valve Voice US, and Mended Hearts issued a joint statement today in response to the Centers for Medicare and Medicaid Services’ proposed decision to cover Transcatheter Aortic Valve Replacement for the treatment of symptomatic aortic valve stenosis through […]

Hoag Clinical Trial Contributes to ‘Eye-Popping’ National Heart Surgery Data

NEWPORT BEACH, Calif., March 18, 2019 /PRNewswire/ — The Jeffrey M. Carlton Heart & Vascular Institute at Hoag, the largest volume cardiovascular program in Orange County, was the first hospital to bring transcatheter aortic valve replacement (TAVR) to the community. Today, the American College of Cardiology (ACC) released data from two trials showing […]

Innovative Cardiovascular Systems Announces First Use of its Next-Generation Emblok™ Embolic Protection System in European Feasibility Study

KALAMAZOO, Mich., March 5, 2019 /PRNewswire/ — Innovative Cardiovascular Solutions, LLC (ICS), a privately held medical device company, today announced the first clinical use of its next-generation Emblok™ Embolic Protection System in patients undergoing transcatheter aortic valve replacement (TAVR) procedures in its European feasibility study. The cases were successfully performed by primary investigator […]

Edwards Lifesciences and Medtronic Lead the U.S. TAVR Market, Despite Threat of New Competition – New Analysis from iData Research

VANCOUVER, British Columbia–(BUSINESS WIRE)–According to a new series of reports by iData Research, the United States cardiac surgery device market is valued at $5.7 billion USD and is forecast to exceed $10 billion by 2024. The largest segment of the cardiac surgery market is the transcatheter heart valve replacement (THVR) […]

Medtronic Announces Clinical Study of Transcatheter Aortic Valve Replacement in Aortic Stenosis Patients with Bicuspid Valves

DUBLIN – September 18, 2018 – Medtronic plc (NYSE:MDT) today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a single-arm study to evaluate the CoreValve Evolut(TM)TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. […]

JenaValve Technology Initiates U.S. Patient Enrollment in Early Feasibility Study of Next-Generation TAVR System for the Treatment of Severe Aortic Stenosis and Severe Aortic Regurgitation

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment in the Early Feasibility Study (EFS) of its next generation JenaValve Pericardial TAVR System using the Everdur™ transcatheter heart valve (THV) and CoronatixTMTransfemoral Delivery Catheter at NewYork-Presbyterian/ […]

Medtronic to Provide Public Comment During CMS Committee Meeting on Volume Requirements for Transcatheter Aortic Valve Replacement (TAVR)

DUBLIN and BALTIMORE – July 25, 2018 – Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, will deliver public comment during the Centers for Medicare & Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting on July 25, which will assess whether scientific evidence supports requiring […]

Nation’s Top Heart Disease Patient Advocates Create Task Force Aimed at Improving Access, Research, and Awareness on Heart Valve Disease Detection and Treatment

WASHINGTON, July 24, 2018 /PRNewswire/ — The nation’s leading heart disease patient advocates announced today the launch of the Heart Valve Disease Policy Task Force, a coalition of non-profit organizations uniting for a common voice in support of improved access, research, and awareness on heart valve disease detection and treatment. The Heart Valve Disease […]

Edwards Comments On CMS Initiation Of National Coverage Analysis For TAVR

IRVINE, Calif., June 28, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today commented on the announcement by the U.S. Centers for Medicare and Medicaid Services (CMS) about a National Coverage Analysis (NCA) for transcatheter aortic valve replacement (TAVR): CMS […]

JenaValve Technology Implants Initial Patients in CE Mark Study for the Treatment of Severe Aortic Regurgitation with Next-Generation TAVR System

IRVINE, Calif.–(BUSINESS WIRE)–JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced initiation of patient enrollment and implantations associated with the CE Mark study of its next generation JenaValve Pericardial TAVR System using the CoronatixTM Transfemoral Delivery Catheter for the percutaneous treatment of patients […]