Coronary/Structural Heart

$100 Million Invested in Clinical Research for Impella

DANVERS, Mass.–(BUSINESS WIRE)–In a milestone for scientific research, Abiomed (NASDAQ: ABMD) has now invested more than $100 million over the past five years in clinical research on the Impella heart pump platform. Abiomed’s commitment to clinical research is detailed on a new webpage that launched today. Abiomed-sponsored research is augmented by two decades of independent physician-led […]

ARCA Biopharma Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support Approval for the First Genetically-Targeted Cardiovascular Drug

WESTMINSTER, Colo., Feb. 20, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a […]

Edwards PASCAL Transcatheter System Receives CE Mark

IRVINE, Calif., Feb. 19, 2019 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients with mitral regurgitation. “Mitral valve disease is complex, varied and […]

CHF Solutions Enters the South American Market with a Distribution Agreement with Bragenix LTDA in Brazil

EDEN PRAIRIE, Minn., Feb. 19, 2019 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), today announced the initiation of a distribution agreement in the Brazilian market with Bragenix, LTDA.  This agreement expands the company’s worldwide sales outreach into South America by entering the largest market in the region. “We have aggressively […]

Final Patient Dosed in Mesoblast Phase 3 Trial of Revascor Cell Therapy for Advanced Heart Failure

NEW YORK and MELBOURNE, Australia, Feb. 19, 2019 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a world leader in development and commercialization of cellular medicines, announced today that the last patient has now been dosed in the Phase 3 events-driven trial of its allogeneic cell therapy product candidate Revascor for advanced chronic […]

Foldax, Inc. Gains Approval to Begin US Clinical Trials of the First and Only Biopolymer Heart Valve Platform

SALT LAKE CITY–(BUSINESS WIRE)–Foldax, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted IDE approval to begin an Early Feasibility Study of the Tria surgical aortic heart valve for the treatment of aortic valve disease. Using breakthrough LifePolymer™ – a proprietary advanced biopolymer material – and […]

Caladrius Biosciences Reports Top-Line Data for the Phase 2a Sanford Project: T-Rex Trial of CLBS03 for Recent Onset Type 1 Diabetes

BASKING RIDGE, N.J., Feb. 13, 2019 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a late-stage therapeutics development biopharmaceutical company with multiple development programs targeting select cardiovascular indications and autoimmune disease, today announced  top-line results from The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase […]

Boehringer Ingelheim and Lilly announce the CAROLINA® cardiovascular outcome trial of Tradjenta® met its primary endpoint of non-inferiority compared with glimepiride

RIDGEFIELD, Conn. and INDIANAPOLIS, Feb. 14, 2019 /PRNewswire/ — Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced CAROLINA® (CARdiovascular Outcome study of LINAgliptin versus glimepiride in patients with type 2 diabetes) met its primary endpoint, defined as non-inferiority for Tradjenta® (linagliptin) versus glimepiride in time to first occurrence of cardiovascular death, non-fatal myocardial infarction or […]

IBM Watson Health and the Broad Institute Launch Initiative to Help Clinicians Predict the Risk of Cardiovascular Disease with Genomics and AI

CAMBRIDGE, Mass., Feb. 13, 2019 /PRNewswire/ — IBM Watson Health (NYSE: IBM) and the Broad Institute of MIT and Harvard are expanding their partnership to help clinicians better predict the possibility of serious cardiovascular diseases. By working with genomics, clinical data and AI, IBM and the Broad Institute hope this three-year project will help provide doctors with tools to […]

Philips launches latest iteration of IntelliSpace Cardiovascular at HIMSS 2019

AMSTERDAM and ORLANDO, Fla., Feb. 13, 2019 /PRNewswire/ — Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the launch of IntelliSpace Cardiovascular 4.1, its next-generation cardiovascular image and information management system. The latest version builds on the existing pediatric reporting capabilities, recognizing the important and unique nature of the pediatric environment. Clinicians can now […]