Coronary/Structural Heart

TherOx Receives FDA Approval for First Heart Attack Treatment Since PCI to Reduce Infarct Size

IRVINE, Calif.–(BUSINESS WIRE)–TherOx, Inc., a privately held medical device company focused on improving treatment of acute myocardial infarction (AMI), announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its SuperSaturated Oxygen (SSO2) Therapy. SSO2 Therapy provides interventional cardiologists with the first and only FDA-approved treatment beyond percutaneous […]

Shockwave Completes Enrollment of Disrupt CAD II Study

SANTA CLARA, Calif., April 03, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, has completed enrollment of its DISRUPT CAD II study, a regulatory-required European post-market registry of coronary IVL. IVL is […]

Esperion Announces Publication in The Journal of the American Heart Association of Bempedoic Acid Study 3 Results

ANN ARBOR, Mich., April 01, 2019 (GLOBE NEWSWIRE) — Esperion (NASDAQ:ESPR) announced today that results from the 345 patient, 24-week, Phase 3, double-blind, placebo-controlled study of bempedoic acid (CLEAR Serenity, also known as Study 3) were published today in the Journal of the American Heart Association (JAHA). Bempedoic acid is being […]

Acasti Pharma Announces Publication of CaPre Bioavailability Study in Leading Peer-Reviewed Journal

LAVAL, Québec, April 01, 2019 (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 (HTG), today announced the publication of […]

Amarin Submits Supplemental New Drug Application (sNDA) to U.S. FDA Seeking New Indication for Vascepa® (icosapent ethyl) to Reduce the Risk of Major Adverse Cardiovascular Events Based on Landmark REDUCE-IT™ Cardiovascular Outcomes Study

BEDMINSTER, N.J., and DUBLIN, Ireland, March 28, 2019 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that, as planned, it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking an expanded indication for its […]

Resverlogix Announces Ninth Positive Data Safety Monitoring Board Recommendation for Phase 3 Study of Apabetalone

CALGARY, Alberta, March 27, 2019 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) (TSX:RVX) today announces the independent Data and Safety Monitoring Board (DSMB) has completed a ninth planned safety review for the Company’s Phase 3, BETonMACE trial for high-risk cardiovascular disease patients and recommended the study continue without modification. The […]

Newly Published Article Demonstrates Ultrafiltration with CHF Solutions’ Aquadex FlexFlow® System Reduces Hospital Costs by Lowering 90-Day Re-admissions and Durations of Stay in Heart Failure Patients

EDEN PRAIRIE, Minn., March 26, 2019 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), today announced the publication of “Ultrafiltration vs. Diuretics for Treatment of Fluid Overload in Patients with Heart Failure:  A  Hospital Cost Analysis” in the Journal of Medical Economics showing that the use of ultrafiltration therapy with the company’s Aquadex […]

Neovasc Wins German Court Appeal; Announces German Court’s Decision to Dismiss CardiAQ’s Claim to Co-inventorship of a European Patent for Tiara™

VANCOUVER, March 21, 2019 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN)(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, today announced that the Higher Regional Court in Munich, Germany, on appeal […]

Zenosense, Inc.: Update on MIDS Medical Test Strip Development

VALENCIA, SPAIN, March 20, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Zenosense, Inc. (OTCQB: ZENO, “Zenosense”, the “Company”), a healthcare technology company focused on the development and commercialization of the MIDS Cardiac™ hand-held technology for the early detection of heart attack at the Point of Care, is pleased to announce an […]

Itamar Medical Advances Simple, Accurate and Reliable Home Sleep Apnea Testing with Launch of WatchPAT™ 300

CAESAREA, Israel, March 20, 2019 (GLOBE NEWSWIRE) — Itamar Medical Ltd. (Nasdaq & TASE: ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced the launch of WatchPAT 300, the next generation WatchPAT system for home sleep […]