Coronary/Structural Heart

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 […]

CryoLife Initiates Enrollment in PROACT Xa Clinical Trial

Study Designed to Evaluate the Use of Apixaban in On-X Aortic Valve Patients ATLANTA, May 7, 2020 /PRNewswire/ — CryoLife, Inc. (NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has initiated enrollment in the PROACT Xa clinical trial, a prospective, randomized, trial to determine if […]

Heart Valve Voice US Statement on Need for Patient Input Regarding Resumption of Cardiovascular Procedures

WASHINGTON–(BUSINESS WIRE)–Heart Valve Voice US is deeply concerned that the patient perspective was omitted from the recent guidance on resuming cardiovascular procedures released in the Journal of the American College of Cardiology and endorsed by more than one dozen medical societies. On April 20, 2020, Heart Valve Voice US cataloged the […]

Quantum Genomics Announces Interim Analysis from Study of Firibastat in Renal Failure Patients

Results demonstrate that firibastat could be used in hypertensive and heart failure patients with concomitant renal dysfunction, subject to dose adjustment. PARIS and NEW YORK, May 06, 2020 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC), a biopharmaceutical company specializing in developing a new drug class that directly […]

FARXIGA Approved in the US for the Treatment of Heart Failure in Patients With Heart Failure With Reduced Ejection Fraction

FARXIGA is the first SGLT2 inhibitor proven to significantly reduce the risk of cardiovascular death and hospitalization for heart failure WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s FARXIGA® (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) […]

BioCardia Announces Positive Preclinical Results Supporting Investigational New Drug Application for Anti-Inflammatory Cell Therapy in Heart Failure

Plans IND Submission for Same Cells to Treat COVID-19 Induced Acute Respiratory Distress Syndrome AN CARLOS, Calif., May 05, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced data from a recent animal study performed by the Company that […]

ZOLL THEROX RECEIVES CE MARK APPROVAL FOR SUPERSATURATED OXYGEN THERAPY

May 4, 2020 — CHELMSFORD, MASS. — ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today it has received CE Mark approval to market and distribute its SuperSaturated Oxygen (SSO2) Therapy System in Europe. SSO2 Therapy provides interventional cardiologists with the first and only clinically proven […]

BioMarin Extends Gene Therapy Leadership with DiNAQOR in a Preclinical Collaboration and License Agreement to Develop Gene Therapies for Rare Genetic Cardiomyopathies

SAN RAFAEL, Calif., May 3, 2020 /PRNewswire/ — BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the company has entered into a preclinical collaboration and license agreement with DiNAQOR AG (DiNAQOR), a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies. DiNAQOR will receive an undisclosed upfront payment […]