Coronary/Structural Heart

Transseptal Solutions Announces First Clinical Use of TSP Crosser™ in the United States

NETANYA, Israel, June 12, 2019 /PRNewswire/ — Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial navigation, announced today the completion of the first TSP Crosser™ transseptal puncture procedure in the US. The procedure was successfully performed by Dr. Latib, the New Medical Director of […]

CorMatrix® Cardiovascular, Inc. receives FDA 510(k) clearance to market the Cor™ PATCH epicardial patch for tissue support and repair in adult patients

ATLANTA, June 11, 2019 /PRNewswire/ — CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA 510(k) clearance for the Cor™ PATCH.  The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients. The Cor™ PATCH epicardial patch is the first epicardial cardiovascular medical device composed of first next […]

Zoll Introduces New Technology to Improve the Management of Acute Heart Failure Patients

CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced the launch of and first patient prescription for the ZOLL µCor™ (pronounced “Micro Core”) Heart Failure and Arrhythmia Management System (HFAMS), designed to help clinicians improve outcomes and reduce hospitalizations for […]

Precision Wellness Validates Performance of Predictive Risk Models to Power Precision Health

PALO ALTO, Calif.–(BUSINESS WIRE)–Precision Wellness, Inc. a Silicon Valley-based company at the intersection of next-generation AI, big data analytics and the latest medical science, today announced the validation of its cardiometabolic disease (CMD) predictive risk engine. The study was performed as part of a sponsored research with Stanford University to evaluate 416,936 […]

Itamar Medical’s WatchPAT™ One, the First and Only Fully Disposable Home Sleep Apnea Test Receives FDA 510(k) Clearance

New system expands WatchPAT access to additional sleep centers by reducing infrastructure needs and eliminating capital requirements; also reduces infection risk for in-patient sleep apnea testing  CAESAREA, Israel, June 06, 2019 (GLOBE NEWSWIRE) — Itamar Medical Ltd. (Nasdaq:ITMR) (TASE:ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices […]

Quantum Genomics Enrolls First Patient in QUORUM Phase IIb Study of Firibastat in Heart Failure Patients

PARIS and NEW YORK, June 06, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in the development of a new drug class that directly targets the brain to treat resistant hypertension and heart failure, announces the enrollment of the first patient in its QUORUM […]

Getinge Opens New Acute Care Section in the Experience Center in Germany

GETINGE, Sweden, June 5, 2019 /PRNewswire/ — Getinge has opened up a brand new acute care section focused on Cardiovascular Procedures in one of its Experience Centers located in Rastatt, Germany. Here, customers have the possibility to learn more about the solutions that Getinge provides to not only aid in the Coronary Artery Bypass Surgery […]

Itamar Medical and BioTel Heart, a Division of BioTelemetry, Expand Collaboration to Offer Itamar’s Total Sleep Solution™ to BioTel Heart Cardiology Customers

CAESAREA, Israel, June 04, 2019 (GLOBE NEWSWIRE) — Itamar Medical Ltd. (NASDAQ and TASE:ITMR), a company that develops, manufacturers and markets non-invasive diagnostic devices for sleep apnea with a focus on the cardiology market, and BioTel Heart, a division of BioTelemetry, Inc. (NASDAQ:BEAT), the leading remote medical technology company focused […]

GORE® CARDIOFORM ASD Occluder Receives FDA Approval for the Treatment of Atrial Septal Defects

FLAGSTAFF, Ariz., June 4, 2019 /PRNewswire/ — W. L. Gore & Associates (Gore) announced the U.S. Food and Drug Administration’s (FDA’s) premarket approval (PMA) of the GORE® CARDIOFORM ASD Occluder for the percutaneous closure of ostium secundum atrial septal defects (ASDs). The FDA approval was supported by data collected from the pivotal stage of the Gore […]

Ancora Heart Enrolls First Patient in U.S. Early Feasibility Study of First-of-Its-Kind Investigational Heart Failure Therapy

SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced the first patient was enrolled in a U.S. early feasibility study evaluating the AccuCinch® Ventricular Repair System as a treatment for patients with reduced ejection fraction systolic heart failure (HFrEF). The first patient […]