IRVINE, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk […]
Coronary/Structural Heart
Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents’ DrugSorb-ATR™ Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants During Urgent Cardiothoracic Surgery
FDA Breakthrough Designation Granted to CytoSorbents’ DrugSorb-ATR for Removal of Apixaban and Rivaroxaban to Reduce the Risk of Serious Bleeding in Urgent Cardiothoracic Surgery MONMOUTH JUNCTION, N.J., Aug. 12, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its […]
Tenax Announces New Publication Highlighting Novel Levosimendan Mechanism of Action in Pulmonary Hypertension Patients with Heart Failure and Preserved Ejection Fraction (PH-HFpEF)
Levosimendan was shown to Reduce Stressed Blood Volume (SBV), a Novel and Highly Relevant Mechanism of Action for PH-HFpEF Patients Stressed Blood Volume Reductions Accompany Previously Reported Improvements in Important Cardiovascular Hemodynamic Measurements Reduction in Stressed Blood Volume Suggests the Effects of Levosimendan are Modulated Through K-ATP Channel Activation and […]
FEops Simulation Technology Supports TRiCares From Initial Design Concepts to a Successful First-in-human
GENT, Belgium–(BUSINESS WIRE)–FEops, a leader in predictive planning for structural heart interventions, is proud to announce that its simulation technology supported TRiCares from initial design concept to a successful first-in-human of the Topaz Tricuspid Valve Replacement (TTVR) system, developed by TRiCares SAS. This is a major step forward towards predictive […]
PhaseBio Pharmaceuticals Achieves Enrollment Milestones Supporting Interim Analysis of REVERSE-IT Global Phase 3 Trial, Enabling Preparation of a BLA submission for Bentracimab for Reversal of Antiplatelet Effects of Ticagrelor
First 143 patients enrolled in the pivotal Phase 3 trial, with top-line results from interim analysis expected later this year Enrollment of patients in the REVERSE-IT trial requiring urgent surgery or invasive procedure now complete, with trial focus shifting to enrollment of patients with uncontrolled major or life-threatening bleeding Phase […]
Chiesi USA Announces Publication of Cost-Consequence Analysis of KENGREAL® (cangrelor) in Cardiac Patients at High Risk of Complications Following PCI in the American Journal of Cardiovascular Drugs
CARY, N.C., Aug. 10, 2021 (GLOBE NEWSWIRE) — Chiesi USA (key-ay-zee), the U.S. affiliate of Chiesi Farmaceutici, an international research-focused healthcare Group (Chiesi Group), today announced the publication of a cost-consequence analysis of KENGREAL® (cangrelor) in patients receiving percutaneous coronary intervention (PCI) in the online edition of the American Journal of Cardiovascular Drugs. KENGREAL […]
PhaseBio Pharmaceuticals and SFJ Pharmaceuticals® Announce Approval of IND Application in China for Bentracimab
Enrollment in the REVERSE-IT global Phase 3 trial from clinical sites in China expected to begin later in 2021 MALVERN, Pa. & SAN DIEGO–(BUSINESS WIRE)–PhaseBio Pharmaceuticals, Inc. (Nasdaq: PHAS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiopulmonary diseases, today announced that the Investigational New […]
Alnylam Completes Enrollment in HELIOS-B Phase 3 Study of Investigational Vutrisiran in Patients with Transthyretin-Mediated (ATTR) Amyloidosis with Cardiomyopathy
− Full Study Enrollment Completed Well Ahead of Schedule − CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has achieved full patient enrollment in its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy in patients […]
BioStable Science & Engineering Initiates European Commercialization of the HAART™ 200 Aortic Annuloplasty Device
First commercial implantations of the HAART 200 Device for Bicuspid Aortic Valve repair performed by Professor Marek Jasinski at the Wroclaw Medical University AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today that the first commercial implantations of its HAART 200 Aortic Annuloplasty Device were performed on Monday, August 2nd by Professor […]
Lexaria Bioscience Corp. (NASDAQ: LEXX) on Forefront of Exciting Hypertension Innovation
NEW YORK, Aug. 06, 2021 (GLOBE NEWSWIRE) — NetworkNewsAudio – Lexaria Bioscience Corp. (NASDAQ: LEXX) announces the availability of a broadcast titled, “Cardiovascular Disease Drug Market Offers Compelling Potential for First Movers, Innovators in the Space.” To hear the AudioPressRelease, please visit: The NetworkNewsAudio News Podcast To view the full editorial, please visit: https://nnw.fm/dJwHD Controlling […]
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