Coronary/Structural Heart

PENUMBRA ANNOUNCES FIRST PATIENT ENROLLED IN STUDY OF MECHANICAL POWER ASPIRATION FOR THROMBUS REMOVAL IN CORONARY VESSELS

Prospective Study to Evaluate Safety and Performance of Indigo® System and CAT RX Aspiration Catheter ALAMEDA, Calif. – October 10, 2019 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced enrollment of the first patient into the CHEETAH study, a prospective, multi-center U.S. study to […]

FDA Classifies Medtronic Sherpa Delivery Catheter Field Action Initiated in March 2019 as Class I Recall

DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]

Corvia Medical’s Interatrial Shunt Device (IASD®) Receives Breakthrough Device Designation For Heart Failure

TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD) for heart failure. The IASD is […]

BioVentrix Enrolls and Treats First Patient in REVIVE-HF European RCT for Ischemic Heart Failure Patients

SAN RAMON, Calif., Oct. 8, 2019 /PRNewswire/ — BioVentrix, Inc. announced the first patient was enrolled and treated  in the REVIVE-HF European  study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TCTM System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. The  patient […]

BioCardia Receives CE Mark Renewal For Helix Biotherapeutic Delivery Catheter And Morph Guide Catheter Through May 2024

SAN CARLOS, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced renewal of the CE Mark for the Helix™ Biotherapeutic Delivery Catheter and Morph® Universal Deflectable Guide Catheter, both used in the delivery of biotherapeutics to the heart. CE Mark renewal enables […]

Abiomed Announces 1,000th Patient Treated with Impella in Japan

TOKYO–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD), a leading provider of breakthrough heart support technologies, announces the 1,000th patient has been treated with the Impella heart pump in Japan. The Impella 2.5 and Impella 5.0 heart pumps are approved for the treatment of drug-resistant acute heart failure and are the first and only percutaneous temporary […]

Diagnomics Releases Cardiovascular Health Panel on Clinical Microarray Platform

SAN DIEGO, Oct. 7, 2019 /PRNewswire/ — Diagnomics Inc., a San Diego-based genetic testing company, is releasing a cardiovascular-focused genetic report through the Illumina Global Screening Array platform. The new clinical report, Cardiac Care, is now added to the company’s established clinical portfolio, Gene Impetus, that emphasizes medically actionable panels generated from genomic data […]

Milestone Pharmaceuticals Announces First Patient Enrolled in NODE-303 Open-label Safety Study of Etripamil in PSVT

MONTREAL and CHARLOTTE, N.C., Oct. 3, 2019 /PRNewswire/ — Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing etripamil for the treatment of cardiovascular indications, today announced that the first patient has been enrolled in the Phase 3 NODE-303 study. NODE-303 is the Company’s open-label, global safety study of etripamil, […]

University Hospitals Completes First Evolut™ PRO+ Case in the World

UH Harrington Heart & Vascular Institute continues reputation as global leader in TAVR   CLEVELAND — Physicians at University Hospitals Cleveland Medical Center completed the first procedure in the world using Medtronic’s new Evolut™ PRO+ TAVR System. Guilherme Attizzani, MD, Director, Valve and Structural Heart Disease Center, and Cristian Baeza, […]

Third-party evaluation confirms safety profile of Philips Stellarex .035″ low-dose drug-coated balloon

Primary safety analysis of Stellarex drug-coated balloon (DCB) three-year data, comprising the largest published, pooled set of randomized controlled trial (RCT) data for a single paclitaxel-based device, shows no difference in mortality between patients treated with the Philips Stellarex DCB and those treated with percutaneous angioplasty, the current standard of […]