VERQUVO Approved for Reduction of Risk of Cardiovascular Death and Heart Failure (HF) Hospitalization Following a Hospitalization for HF or Need for Outpatient Intravenous (IV) Diuretics in Adults with Symptomatic Chronic Heart Failure and Ejection Fraction Less than 45% VERQUVO is the First Soluble Guanylate Cyclase Stimulator, Approved to Treat […]
Coronary/Structural Heart
Cardiovascular Systems, Inc. Receives CE Mark for Diamondback 360® Coronary Orbital Atherectomy System
One solution to both reduce surface calcium and fracture deep calcium 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 it has received CE Mark for its Diamondback […]
Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)
SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire/ — Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) […]
Caladrius Biosciences Treats First Patient in the Phase 2b FREEDOM Trial of CLBS16 for the Treatment of Coronary Microvascular Dysfunction
Initiation of the Phase 2b FREEDOM trial represents the next step in development of CLBS16 as a potential breakthrough treatment for the millions of sufferers of CMD in the U.S., most of whom are women Patient enrollment underway at The Christ Hospital Health Network in Cincinnati (OH) and Mayo Clinic […]
Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure
THE WOODLANDS, Texas, Jan. 14, 2021 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to […]
HCPLive® Adds The American Society for Preventive Cardiology to Its Strategic Alliance Partnership Program
CRANBURY, N.J.–(BUSINESS WIRE)–HCPLive® and The American Journal of Managed Care® (AJMC®) are excited to announce the addition of The American Society for Preventive Cardiology (ASPC) to their Strategic Alliance Partnership (SAP) programs. “We’re very honored to be able to join forces with ASPC to help promote the prevention of cardiovascular disease,” said Mike Hennessy Jr., […]
Elixir Medical Announces First Patient Treated in BIOADAPTOR Randomized Controlled Trial of DynamX Coronary Bioadaptor System
International Trial to Compare Bioadaptor, a Novel Coronary Artery Implant Designed to Adapt to Vessel Physiology, with Traditional Drug Eluting Stents MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced that the first patient has been treated in the BIOADAPTOR randomized controlled trial (RCT) of the DynamX™ […]
Cytokinetics Announces First Patient Dosed in Cohort 2 of Redwood-HCM
Company Earns $2.5 Million Milestone Payment from Ji Xing Pharmaceuticals SOUTH SAN FRANCISCO, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Inc. (Nasdaq: CYTK) today announced that the first patient has been dosed in Cohort 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), an ongoing Phase 2 clinical trial of […]
Positive preliminary data from Acarix’s exploratory heart failure study SEISMO
Press release Malmö, Sweden, January 13, 2021 Positive preliminary data from Acarix’s exploratory heart failure study SEISMO Acarix AB (publ) today announced positive preliminary data from the exploratory SEISMO study, using its modified CADScor®System on a potential heart failure application. The SEISMO trial was initiated in June 2018 to evaluate […]
Mesoblast Presents Heart Failure Phase 3 Trial Results at Investor Healthcare Conference
NEW YORK, Jan. 11, 2021 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced that its Chief Executive Officer, Dr Silviu Itescu, today presented additional data from the landmark DREAM-HF Phase 3 trial in patients with chronic heart failure. The presentation materials […]
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