Coronary/Structural Heart

Paragonix Technologies, Inc., Announces AdventHealth’s Adoption of Paragonix SherpaPak™ Cardiac Transport System

Paragonix SherpaPak™ Cardiac Transport System is the only FDA cleared and CE marked device that safeguards hearts between donor and recipient patients CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced AdventHealth (Orlando, Florida) has adopted its Paragonix SherpaPak™ Cardiac Transport System (CTS) for the preservation of donor hearts for transplantation. A recent […]

Mentice Expands Coronary Product Portfolio with the Introduction of Coronary Intermediate Software

STOCKHOLM, March 12, 2020 /PRNewswire/ — Mentice AB (STO: MNTC), a world leader in simulation solutions for endovascular therapies, introduces Coronary Intermediate as the latest software addition to the Coronary Product Portfolio. Coronary Intermediate follows the introduction of Coronary Essentials three months earlier at the 20th International Meeting on Simulation in Healthcare […]

VisCardia Announces Completion of Its VisONE Heart Failure Pilot Study

PORTLAND, Ore., March 9, 2020 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today it has completed the company’s First-in-Human study of the implantable VisONE® system for medically refractory heart failure (HF) patients with reduced ejection fraction (HFrEF) and preserved ventricular synchrony. The VisONE Heart Failure pilot was a prospective, […]

SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) Now FDA Approved

TUCSON, AZ, March 09, 2020 (GLOBE NEWSWIRE) — With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy. The 50cc TAH-t is 37.5% smaller […]

Acasti Pharma Awarded Notice of Allowance for Additional Composition of Matter and Method of Use Patents in the United States and Mexico

Patent upheld in Japan following opposition filings and subsequently allowed Completes TRILOGY 1 audits and accelerates plans to submit FDA meeting request by the end of March LAVAL, Québec, March 11, 2020 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator […]

Correvio Partners with Hong Kong Teson Pharma Limited for the Commercialization of Aggrastat® in China

VANCOUVER and HONG KONG, March 10, 2020 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, and Hong Kong Teson Pharma Limited (Teson), a privately-held pharmaceutical company, today announced that Correvio International Sàrl, a wholly owned subsidiary of Correvio, and Teson have entered into an exclusive agreement […]

FDA Inks Research Collaboration Agreement with AnaBios Focused on Human Primary Cardiomyocytes

SAN DIEGO, March 10, 2020 /PRNewswire/ — Today, AnaBios announced a Research Collaboration Agreement (RCA) with the U.S. Food and Drug Administration (FDA) to study adult human primary cardiomyocytes as a reference for cellular properties and drug-induced effects on cardiac function. Under the RCA, the FDA Center for Drug Evaluation and Research (CDER) […]

Carag First-ever Septal Occluder With Bioresorbable, Metal-free Framework Available to Patients Through New European Registry

First 3-year-old patient successfully implanted and discharged from hospital in Berlin BAAR, Switzerland and BERLIN, March 10, 2020 /PRNewswire/ — CARAG AG, a Swiss privately held medical device development company, announced today the successful implantation of the first-ever transcatheter septal occluder with bioresorbable, metal-free framework, as part of a new international post-market registry. The […]

NanoSurface Bio Executes Exclusive License of Heart-on-Chip Technology Launched Into Space

SEATTLE–(BUSINESS WIRE)–NanoSurface Biomedical announced today that it has executed an exclusive IP license agreement related to innovative heart-on-chip technology developed by researchers at the University of Washington (UW). An experimental system built from the same heart-on-chip technology was launched into space on Friday, March 6, 2020 at 11:50 PM EST aboard […]

CARMAT Announces that It Has Achieved Record Individual Support of 2 Years With Its Bioprosthesis

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR) (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, today announces that it has reached a major milestone by achieving record individual support of 2 years […]