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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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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, […]
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, […]
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 […]
