The Latest Cardiac and Vascular News
SILVER SPRING, Md.–(BUSINESS WIRE)–Aziyo® Biologics, Inc., a fully integrated regenerative medicine company, today announced the publication of results from its landmark RECON study in the Journal of Cardiothoracic Surgery1. The prospective, single arm study included 1,420 patients in 42 hospitals across the United States and represents the largest pericardial-closure study conducted to date. […]
LAKE OSWEGO, Ore., April 10, 2019 /PRNewswire/ — BIOTRONIK today announced the United States (US) commercial launch of the PK Papyrus® covered coronary stent system for use in the emergency treatment of acute coronary perforations.1,2 More than 800,000 percutaneous coronary intervention procedures are performed annually in the US3 and fewer than 8,000 require a covered stent, classifying PK […]
EDEN PRAIRIE, Minn., April 09, 2019 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS) today announced that Oklahoma Heart Institute in Tulsa, Oklahoma, has launched an ultrafiltration program using the Aquadex FlexFlow® system to assist in the management of fluid overload in patients following cardiac surgery and patients suffering from heart […]
NASHUA, N.H., April 9, 2019 /PRNewswire/ — Conformal Medical, Inc., developer of the Conformal Left Atrial Appendage Seal for LAA occlusion, reports the first human use of its proprietary technology for the prevention of stroke in patients with atrial fibrillation (AFib). The case was performed by Robert Sommer, MD at New York-Presbyterian/Columbia University Medical […]
DANVERS, Mass.–(BUSINESS WIRE)–Three years ago this week, Abiomed’s (NASDAQ: ABMD) Impella heart pumpreceived its FDA PMA approval for AMI cardiogenic shock. At the time of Impella’s FDA PMA approval, the cardiogenic shock survival rate to explant in the Impella Quality Assurance (IQ) Database was 51% in the United States1. Today, Impella heart pumps, combined […]
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 […]
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 […]
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 […]
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 […]
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 […]
