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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 […]

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 […]

Novoheart Grants Stock Options

VANCOUVER, British Columbia, Oct. 08, 2019 (GLOBE NEWSWIRE) — Novoheart Holdings Inc. (“Novoheart” or the “Company”) (TSXV: NVH; FWB: 3NH) announces that it has granted incentive stock options to purchase an aggregate of 1,150,000 common shares of the Company (the “Options”) to non-executive directors of the Company. Option Grants The Options have […]

First Patient in Middle East Treated With Cardiovascular Systems, Inc. Peripheral Orbital Atherectomy System

Introduction of Orbital Atherectomy Expands Treatment Options for Patients with Peripheral Artery Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in the United […]

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 […]

Kardium® announces successful results from the GLOBAL-AF study

VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc. today announced that the Globe® mapping and ablation system has successfully demonstrated safety and efficacy in the GLOBAL-AF study. The results of the study were published in the Journal of Cardiovascular Electrophysiology. The study demonstrated a 76% percent freedom from atrial fibrillation at 12 months after a […]

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 […]