Coronary/Structural Heart

CARMAT Confirms the Definitive Approval of its “Forfait Innovation” Dossier by the French National Authority for Health (HAS)

With this favorable opinion, CARMAT will request financing of its device within the framework of a clinical study in France 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 […]

Windtree Presents New Istaroxime Phase 2b Study Analysis at the American College of Cardiology (ACC) Congress

Efficacy of 24 Hour Istaroxime Infusion is Similar Between Caucasian and Asian Patients Hospitalized for Acute Heart Failure WARRINGTON, Pa., April 6, 2020 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, […]

SHOCKWAVE COMPLETES ENROLLMENT IN PIVOTAL STUDY FOR CORONARY INTRAVASCULAR LITHOTRIPSY

Last Patient Enrolled in DISRUPT CAD III, the U.S. FDA IDE Study for IVL in Severely Calcified Coronary Arteries SANTA CLARA, Calif., April 06, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, […]

Mardil Medical Completes Treatment Of Third Patient In VenTouch™ Device Trial

MINNEAPOLIS, April 3, 2020 /PRNewswire/ — Mardil Medical, Inc., today announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch™ device.  VenTouch is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles in patients suffering from Type IIIb Functional Mitral Valve […]

CHF Solutions Doubles Production Staff of Aquadex SmartFlow™ Consoles Due to Hospital Demand

EDEN PRAIRIE, Minn., April 02, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, announced that it has doubled the production staff that builds its next generation Aquadex SmartFlow consoles in response to increased demand from […]

BIOCARDIA ANNOUNCES POSITIVE DSMB RECOMMENDATION TO CONTINUE PHASE III PIVOTAL CARDIAMP HEART FAILURE STUDY, AS PLANNED

Company to Host Conference Call with National Co-Principal Investigators Today at 4:15 p.m. ET to Provide Study Updates SAN CARLOS, Calif., March 31, 2020 (GLOBE NEWSWIRE) — BioCardia (Nasdaq: BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the independent Data Safety Monitoring Board (DSMB) […]

Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second Half of June

LAVAL, Québec, April 01, 2020 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and   commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it has filed […]

Horizon Discovery and Pharmahungary Report Positive Early-Stage Results for Novel Micro-RNA Therapeutic for Ischemic Heart Diseases

Micro-RNA compound found suitable for further development following favorable pharmacokinetic and pharmacodynamic study results CAMBRIDGE, England & BUDAPEST, Hungary–(BUSINESS WIRE)–Horizon Discovery Group plc (LSE: HZD) (“Horizon”, “the Company” or “the Group”), a global leader in the application of gene editing and gene modulation for cell line engineering, and Pharmahungary Group, […]

Edwards SAPIEN 3 Valve Shows Excellent Results At 2 Years

IRVINE, Calif., March 29, 2020 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced 2-year results of the randomized PARTNER 3 trial comparing treatment with the SAPIEN 3 valve to surgery in patients with severe symptomatic aortic stenosis (AS) at […]

FDA Approves Next-Generation ZOLL® TherOx System for Widowmaker Heart Attack Patients

First and Only Treatment to Reduce Heart Muscle Damage Following Angioplasty and Stenting CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei Group company that manufactures medical devices and related software solutions, announced today it has received U.S. Food and Drug Administration (FDA) approval of the second-generation TherOx System, which provides SuperSaturated […]