The Latest Cardiac and Vascular News
Successful DynamX Bioadaptor Live Case Presented at Singapore Live MILPITAS, Calif.–(BUSINESS WIRE)–Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced the 24-month clinical results for the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology. The results were presented at the 30th Annual Live […]
Company’s LifePolymer Material Used in First Polymer Heart Valves Ever Approved by FDA for Use in Clinical Trials SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced publication of a research paper in Advanced NanoBiomed Research that concluded that its LifePolymer™ biopolymer “exhibits ideal biomaterial properties for the flexible leaflets of a totally synthetic […]
Innovative technology offers an implant-free approach for individuals with chronic heart failure AUSTIN, Texas–(BUSINESS WIRE)–Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology offers a no-implant interatrial […]
ESC Heart Failure Giallauria et al. December 2020 An individual patient data meta‐analysis was conducted from 3 prospective studies that enrolled 209 heart failure patients with reduced ejection fraction patients and functional mitral regurgitation (FMR). Patients implanted with the Carillon Mitral Contour System or control were assessed for 12-month outcomes […]
– New national reimbursement enables access to transcatheter mitral valve repair procedures with MitraClip for people with secondary mitral regurgitation, significantly expanding the eligible patient population ABBOTT PARK, Ill., Jan. 20, 2021 /PRNewswire/ — Abbott (NYSE: ABT) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) revised its National Coverage Determination (NCD) […]
VERQUVO Approved for Reduction of Risk of Cardiovascular Death and Heart Failure (HF) Hospitalization Following a Hospitalization for HF or Need for Outpatient Intravenous (IV) Diuretics in Adults with Symptomatic Chronic Heart Failure and Ejection Fraction Less than 45% VERQUVO is the First Soluble Guanylate Cyclase Stimulator, Approved to Treat […]
One solution to both reduce surface calcium and fracture deep calcium ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that it has received CE Mark for its Diamondback […]
SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire/ — Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) […]
Initiation of the Phase 2b FREEDOM trial represents the next step in development of CLBS16 as a potential breakthrough treatment for the millions of sufferers of CMD in the U.S., most of whom are women Patient enrollment underway at The Christ Hospital Health Network in Cincinnati (OH) and Mayo Clinic […]
THE WOODLANDS, Texas, Jan. 14, 2021 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to […]
