ROCKVILLE, Md., Jan. 24, 2022 /PRNewswire/ — Today, the Heart Failure Society of America (HFSA) released a review, Economic Issues in Heart Failure in the United States, in the Journal of Cardiac Failure (JCF). The review examines the growing economic burden of heart failure for patients and the health care system in the United States, providing a summary of […]
Coronary/Structural Heart
Imara Announces FDA Clearance of Investigational New Drug Application (IND) for Tovinontrine (IMR-687) for Heart Failure with Preserved Ejection Fraction (HFpEF)
Expanding patient base and potential of Imara’s small molecule oral inhibitor of phosphodiesterase-9 (PDE9) alongside hemoglobin disorders Phase 2 trial aims to select HFpEF patients with enriched PDE9 expression for targeted approach to a heterogeneous disease Study initiation planned for second quarter of 2022 BOSTON, Jan. 25, 2022 (GLOBE NEWSWIRE) […]
Chiesi USA Announces New Publication of Post Hoc Analysis on Timing of Ischemic Events in Cardiac Patients and Role of KENGREAL® (cangrelor) in Reducing Risk
Post hoc analysis of the CHAMPION PHOENIX clinical trial demonstrates that the majority of ischemic events occurred early in percutaneous coronary intervention (PCI), and KENGREAL® (cangrelor) treatment significantly reduced these events in the first two hours post-randomization compared to clopidogrel (4.1% vs 5.4%, p=0.002) CARY, N.C., Jan. 25, 2022 (GLOBE […]
Matinas BioPharma Provides Business Update and 2022 Strategic Outlook
– End of Phase 2 Meeting with FDA Provides Pathway to NDA Submission for MAT2203 Following Confirmatory Data to be Generated in an Additional Cohort; Cohort 5 in Ongoing EnACT Trial – – Cohort 4 of EnACT (all oral induction regimen) Underway With Six Patients Enrolled and Topline Interim Data […]
Eplontersen granted Orphan Drug Designation in the US for transthyretin amyloidosis
WILMINGTON, Del., January 24, 2022 – Eplontersen has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of transthyretin-mediated amyloidosis, a systemic, progressive and fatal condition. Eplontersen, formerly known as IONIS-TTR-LRx, is a ligand-conjugated antisense (LICA) investigational medicine currently in […]
Alnylam Presents Positive 18-Month Results from HELIOS-A Phase 3 Study of Investigational Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy
– Vutrisiran Met All 18 Month Secondary Endpoints, Including Statistically Significant Improvements in Neuropathy Impairment, Quality of Life (QoL), Gait Speed, Nutritional Status and Overall Disability, Relative to External Placebo – – Vutrisiran Continued to Demonstrate Halting or Reversal of Polyneuropathy, with Improvements in Neuropathy Impairment and QoL Relative to […]
United Therapeutics Corporation Announces Historic Achievements in its Xenotransplantation Programs
UKidney™ procedure data published in the American Journal of Transplantation; the first such data published in a peer-reviewed journal UHeart™ recipient patient reaches a two-week milestone post-transplant UThymoKidney™ procedure represents a historic first preclinical human model study SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (UT) (Nasdaq: UTHR), […]
Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon
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, today, along with OrbusNeich Medical Company Ltd (OrbusNeich®), announced FDA PMA approval of OrbusNeich’s Scoreflex® NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter […]
Neovasc Announces Publication Supporting the Neovasc Reducer™ Device
VANCOUVER and MINNEAPOLIS, Jan. 20, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc, Inc. (Neovasc or the Company) (NASDAQ, TSX: NVCN) today announced the publication of an article entitled, “The Effectiveness of CS Reducer for the Treatment of Refractory Angina – a Meta-Analysis” in the Canadian Journal of Cardiology. The article’s lead author and senior authors are […]
GORE® CARDIOFORM Septal Occluder Marks 10 Years of Improving Lives
After a decade of clinical use* and more than 50,000 devices sold globally, the GORE® CARDIOFORM Septal Occluder continues a trusted legacy of safely advancing care. FLAGSTAFF, Ariz., Jan. 19, 2022 /PRNewswire/ — W. L. Gore & Associates (Gore) today announced that the GORE® CARDIOFORM Septal Occluder has achieved 10 years of clinical […]