Coronary/Structural Heart

Caladrius Biosciences Reports Positive Results for CLBS16 from the ESCaPE-CMD Trial at American Heart Association Scientific Sessions 2019

Single administration of CLBS16 durably improves heart function and symptoms with no cell-related adverse events CLBS16 cell therapy shows promise as a significant advancement in treatment of Coronary Microvascular Dysfunction (CMD), a condition that disproportionately afflicts women PHILADELPHIA, Nov. 16, 2019 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq: CLBS), a late-stage biopharmaceutical […]

Applied Therapeutics Announces Presentation of Clinical Data Highlighting AT-001 for the Treatment of Diabetic Cardiomyopathy at the American Heart Association (AHA) Scientific Sessions 2019

NEW YORK, Nov. 15, 2019 (GLOBE NEWSWIRE) — Applied Therapeutics Inc. (Nasdaq:APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced the presentation of data at the American Heart Association (AHA) Scientific Sessions 2019 in […]

Amarin Announced FDA Advisory Committee Voted Unanimously (16-0) to Recommend Approval of Vascepa® (icosapent ethyl) Capsules Label Expansion to Reduce Cardiovascular Risk Based on Landmark REDUCE-IT® Outcomes Trial

Cardiovascular disease events like heart attacks, stroke and death affect millions of patients in the United States and are estimated to cost $500 billion annually Millions of high-risk patients with cardiovascular disease could benefit from this cost-effective therapy if expanded label receives FDA approval; PDUFA date is December 28 DUBLIN, […]

Amgen And The Duke Clinical Research Institute Announce Initiation Of First Large-Scale Registry To Evaluate Real-World Lipid Management And The Effectiveness Of PCSK9 Inhibitors

New Registry, cvMOBIUS, Will Assess Lipid Therapies and Five-Year Cardiovascular Outcomes in 8,500 High-Risk Patients With a Recent Atherosclerotic Cardiovascular Disease Event THOUSAND OAKS, Calif., Nov. 15, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) in collaboration with the Duke Clinical Research Institute (DCRI) today announced plans to initiate the Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors […]

Neovasc Reducer™ Therapy for Refractory Angina Exceeds 200th Patient Milestone in Germany

VANCOUVER and MAINZ, Germany, Nov. 12, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced today that a […]

MyoKardia Announces Positive Topline Data from its Phase 2 MAVERICK-HCM Clinical Trial of Mavacamten

Achieved Primary Study Objective of Safety and Tolerability in Patients with Non-obstructive HCM Significant Reductions in Biomarkers of Cardiac Stress Observed in Patients on Treatment vs. Placebo Data Support Advancement of Mavacamten in Non-obstructive HCM; Regulatory Update Anticipated in the First Half of 2020 Phase 2 Study of Mavacamten Targeting […]

REDUCE-IT® USA Results, in Prespecified Subgroup Analyses of Landmark REDUCE-IT Global Study, Showed Robust Cardiovascular Risk Reductions Across a Variety of Study Endpoints, Including Cardiovascular Death and All-Cause Mortality

Prespecified Analysis of 3,146 Patients in the USA Enrolled in REDUCE-IT Showed 31% Relative Risk Reductions for First Occurrence of Both 5-Point MACE and 3-Point MACE Significant Reductions Shown in All Predefined Composite and Individual Cardiovascular Endpoints, Including Cardiovascular Death and All-Cause Mortality Tolerability and Safety Findings Consistent with Full […]

MyoKardia Announces 48-week Data from PIONEER-OLE Study of Mavacamten

Mavacamten’s Safety and Efficacy Profile in the PIONEER Study Maintained Through One Year in Open-Label Extension Study of 12 Patients with Symptomatic, Obstructive HCM Evidence Suggests Mavacamten’s Favorable Impact on Cardiac Structure Conference Call Today at 8:30 a.m. ET (5:30 a.m. PT); Data Presentation at American Heart Association Scientific Sessions on Monday, […]

New data from the Phase III DAPA-HF trial showed FARXIGA reduced the worsening of heart failure or cardiovascular death in HFrEF patients with and without chronic kidney disease

AstraZeneca today announced a pre-specified sub-analysis from the landmark Phase III DAPA-HF trial investigating FARXIGA® (dapagliflozin) for the treatment of heart failure (HF). The data showed that FARXIGA on top of standard of care reduced the incidence of the primary composite endpoint of cardiovascular (CV) death or worsening of HF […]

Shockwave Initiates Study of Coronary Intravascular Lithotripsy in Japan

First Patient Enrolled in DISRUPT CAD IV Clinical Study for Treatment of Severely Calcified Coronary Arteries SANTA CLARA, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the company […]