Coronary/Structural Heart

Edwards PASCAL Transcatheter Valve Repair System Receives European Approval For Tricuspid Repair

IRVINE, Calif., May 18, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has received CE Mark for the Edwards PASCAL transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation (TR). “Although the […]

Clinical Trial Outcomes of Recardio’s Dutogliptin Published in the British Journal of Pharmacology

Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced publication of the outcomes of the Phase 1 clinical trial of its lead candidate dutogliptin. Entitled “Safety, tolerability, pharmacokinetics, and pharmacodynamics of parenterally administered dutogliptin: A prospective dose escalating trial”, the article can be accessed here: https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.14208 […]

Caladrius Biosciences Reports Positive Full Results for CLBS16 from the ESCaPE-CMD Trial at SCAI 2020 Scientific Sessions

Single administration of CLBS16 durably improves heart function and symptoms in patients with coronary microvascular dysfunction BASKING RIDGE, N.J., May 14, 2020 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse, not manage, […]

VASCEPA® (icosapent ethyl) Shows Significant Reduction in Coronary Revascularization, Including Coronary Stenting and Cardiac Bypass Surgery, in Prespecified and Post Hoc Analyses of Landmark REDUCE-IT® Study

First and total coronary revascularization event reductions of 34% and 36%, respectively, shown with VASCEPA in prespecified tertiary endpoint analyses Results of prespecified tertiary endpoint analyses consistent across different types of coronary revascularization procedures, including urgent, emergent, and elective interventions Percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) […]

Acceleron Announces Publication in Science Translational Medicine Describing the Underlying Biology Behind Sotatercept’s Potential as a Novel Therapy in Pulmonary Arterial Hypertension

Preclinical research of murine version of sotatercept reveals significant role of key TGF-beta superfamily proteins, including activin and growth differentiation factor ligands, in pulmonary vascular disease; points to therapeutic strategy in pulmonary arterial hypertension (PAH) CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery, development, […]

Ostial Corporation Reaches 15,000 FLASH™ System Units Sold

Novel dual-balloon technology designed for true 360° stent apposition CAMPBELL, Calif., May 12, 2020 /PRNewswire/ — Ostial Corporation (Ostial), a private medical technology company focused on addressing the clinical challenges of aorto-ostial interventions, today reached a new milestone, passing the mark of 15,000 commercial units sold of its FLASH™ Aorto-Ostial Angioplasty System (FLASH System) in […]

Daniel R. Goldstein, MD, Named Incoming Editor-in-Chief of the Journal of Heart and Lung Transplantation

ADDISON, Texas, May 12, 2020 (GLOBE NEWSWIRE) — The International Society for Heart and Transplantation, which publishes the Journal of Heart and Lung Transplantation, named Daniel R. Goldstein, MD, the new editor-in-chief of the Journal. Dr. Goldstein is the Eliza Maria Mosher Collegiate Professor in Internal Medicine and Director of the […]

MyoKardia Announces Primary and All Secondary Endpoints Met in Phase 3 EXPLORER Clinical Trial of Mavacamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Highly Statistically Significant Improvements in NYHA Classification, Peak VO2, and LVOT Gradient Observed vs. Placebo Mavacamten Well Tolerated; Safety Results Comparable to Placebo U.S. Regulatory Submission Planned for Early 2021 MyoKardia to Host Conference Call at 8:00 a.m. ET BRISBANE, Calif., May 11, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) […]

CytoSorb® is E.U. Approved to Remove Rivaroxaban, a Leading Factor Xa Inhibitor and Novel Oral Anticoagulant, During On-Pump Cardiothoracic Surgery

Expands CytoSorb E.U. label that now includes the reduction of two major blood thinners, rivaroxaban (Xarelto®) and ticagrelor (Brilinta®), during on-pump cardiothoracic surgery with the goal of reducing serious perioperative bleeding complications MONMOUTH JUNCTION, N.J., May 12, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purification, announces that CytoSorb® is […]

FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure

Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., May 8, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin […]