The Latest Cardiac and Vascular News
TAMPA, Fla., March 25, 2021 /PRNewswire/ — Keystone Heart, Ltd., a medical device innovator driven to redefine the standard of structural heart care, today announced an exclusive distribution agreement with InterValve Medical Inc. to sell and market their portfolio of balloon aortic valvuloplasty products, in the United States. InterValve Medical, a Venus Medtech […]
Milestone achieved as company prepares for next stage of commercial growth and expansion LISLE, Ill., March 23, 2021 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced the 100th global implant of the Cordella Pulmonary Artery Pressure Sensor (Cordella Sensor) […]
Collaboration to focus on the continued development of chronic heart failure treatment SERCA2a activator compounds adding to Windtree’s acute treatment Istaroxime WARRINGTON, Pa., March 22, 2021 /PRNewswire/ — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology and medical device company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today […]
LA ROCHELLE, France–(BUSINESS WIRE)–Regulatory News: VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / eligible for the PEA/SME), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has obtained ISO 9001 certification for its Quality Management System (QMS) deployed on its three sites. […]
U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]
SOUTH SAN FRANCISCO, Calif., March 18, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial […]
BRADENTON, Fla.–(BUSINESS WIRE)–PaceMate™, the leading digital healthcare company in compliant cardiac data management, announced today its recent listing with premier electronic health record company Epic. As part of the App Orchard developer program, PaceMate™’s bidirectional, EHR-integrated application is now available to Epic’s vast network of healthcare customers as a comprehensive, […]
MONMOUTH JUNCTION, N.J., March 16, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO) announces the filing of an Investigational Device Exemption (IDE) application to conduct the clinical study, “Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T),” in the United States to support an initial FDA regulatory approval. This is being done under the previously announced FDA Breakthrough Designation granted for the removal of […]
28% and 32% significant reductions in first and total strokes, respectively, demonstrated with VASCEPA compared to placebo, as well as reductions in first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke, in statin-treated patients with elevated cardiovascular risk Consistent reductions in overall stroke and in ischemic stroke […]
PORTLAND, Ore., March 16, 2021 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today that the American Medical Association (AMA) has issued (ten) 10 new Current Procedural Terminology (CPT®) Category III codes in support of the implant procedure and management of Synchronized Diaphragmatic Stimulation (SDS®) therapy as provided through VisCardia’s […]
