Tag: TAVR

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 […]

Medtronic Evolut(TM) PRO TAVR System with Advanced Sealing Maintains Excellent Outcomes Over Time

DUBLIN and DENVER – November 2, 2017 – Medtronic plc (NYSE:MDT) today presented new data at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting showcasing the excellent clinical performance of the Evolut(TM) Transcatheter Aortic Valve Replacement (TAVR) platform. Six-month data from the newest-generation Evolut PRO System demonstrated continued benefits of its unique valve […]

BioTrace Medical Announces Key Events Featuring Tempo® Temporary Pacing Lead at TCT 2017

SAN CARLOS, Calif.–(BUSINESS WIRE)–BioTrace Medical, Inc., today announced the company’s key activities at the Transcatheter Cardiovascular Therapeutics (TCT) 2017 meeting, which will take place October 29 – November 2 at the Colorado Convention Center in Denver. The company’s Tempo® Temporary Pacing Lead will be featured in a breakfast symposium titled: “The […]

Bay Area’s Claret Medical Nabs $14.5M

SANTA ROSA, Calif.–(BUSINESS WIRE)– Claret Medical, developer of the Sentinel® Cerebral Protection System, the first FDA-cleared cerebral protection device for transcatheter aortic valve replacement (TAVR), today announced that it has closed on a Series C financing of $14.5 million led by Lightstone Ventures, with participation from existing investors Easton Capital, HealthCor Partners, […]