Tag: TAVR

Ahead of an Imminent Medicare Coverage Decision, New Morning Consult Survey Shows More than 2/3 of Americans Support Broadening Access to a Less-Invasive Heart Valve Disease Treatment for Rural Communities

WASHINGTON, June 17, 2019 /PRNewswire/ — Ahead of a final decision from the Centers for Medicare & Medicaid Services (CMS) that may continue to limit Medicare coverage for a heart valve disease treatment called transcatheter aortic valve replacement (TAVR), a new survey shows […]

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 […]

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 […]

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™ […]

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 […]

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 […]