Tag: TAVR

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 […]

Saranas Closes $2.8 Million in New Financing

Saranas Inc., a medical device company with innovative technology for real-time detection and monitoring of internal bleeding during endovascular procedures, today announced the completion of a $2.8 million Series C funding round. The financing follows the company’s recent De Novo application to the U.S. Food and Drug Administration (FDA) for the Early Bird™ […]

Emboline, Inc. Completes Funding Of Over $10 Million

SANTA CRUZ, Calif., April 19, 2018 /PRNewswire/ — Emboline, Inc., an emerging medical device company with a game-changing device for total embolic protection during transcatheter aortic valve replacement (TAVR) procedures, announced today that it has completed a Series B funding round totaling over $10 million. The funding includes $3 million in new […]

Clinical Trials Show Strong Long-Term Performance with the Medtronic CoreValve TAVR System

Presented at ACC.18, Five-Year Follow-up from the CoreValve Extreme Risk and NOTION Studies Show Sustained Valve Function and Durability Over Time DUBLIN and ORLANDO – March 10, 2018 – Medtronic plc (NYSE: MDT) today unveiled outcomes from the CoreValve U.S. Pivotal Extreme Risk Study and the real-world NOTION trial (Nordic Aortic […]

From Planning to Post-Op, Canon Medical Systems Delivers a Complete Suite of Structural Heart Imaging Solutions

TUSTIN, Calif.–(BUSINESS WIRE)–From accurate, precise planning to successful implementation of aortic and mitral valve replacements and post-operative evaluation, Canon Medical Systems USA, Inc. delivers a complete suite of imaging solutions for structural heart interventions. Features such as the Volumetric Scan Mode on the Aquilion™ ONE / GENESIS Edition, which enables the heart […]

New Self-Expanding Valve Addresses the Achilles’ Heel of TAVR

By Ken Dropiewski, Prime-Core Executive Search (ken@prime-core.com) The paravalvular leak (PVL) has long been considered the Achilles’ heel of TAVR. The frequent complication of aortic valve replacement occurs at a much higher rate after the transcatheter approach than conventional surgical replacement. Research has indicated that PVL is linked to late […]