The Latest Cardiac and Vascular News
VANCOUVER and MINNEAPOLIS, Aug. 17, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has filed a supplement to the COSIRA-II Investigational Device Exemption (IDE) Study with the U.S. Food and Drug Administration (FDA). Following multiple productive discussions with FDA over the […]
Advanced design makes sample collection simple, efficient, and safe SOUTH JORDAN, Utah, Aug. 16, 2021 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy, […]
SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ — Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
