ATLANTA, Sept. 26, 2019 /PRNewswire/ — CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced it has completed enrollment of the adult arm of its FDA early feasibility IDE study for the Cor® TRICUSPID ECM® cardiac valve* for adults with endocarditis and for pediatric patients with congenital heart valve disease. The Cor® TRICUSPID ECM® valve […]
Coronary/Structural Heart
Ancora Heart Announces Positive Safety and Efficacy Data from Study of First-of-Its-Kind Investigational Heart Failure Therapy
SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced results from an interim analysis of heart failure patients treated in the CorCinch FMR study, a U.S. early feasibility study evaluating the safety of the investigational AccuCinch® Ventricular Repair System designed for the […]
Abiomed Receives FDA PMA Approval for Impella 5.5 with SmartAssist, a Minimally Invasive, Forward Flow Heart Pump
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed’s (NASDAQ: ABMD) newest heart pump, the Impella 5.5 with SmartAssist, has received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is: Minimally invasive, eliminating the need for a […]
OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent
HONG KONG, Sept. 25, 2019 /PRNewswire/ — OrbusNeich Medical K.K. of Tokyo Japan has announced that the Japan Ministry of Health, Labour, and Welfare (MHLW) has granted Shonin market approval for the COMBO Plus Coronary Stent. The COMBO Plus Coronary Stent is the first drug-eluting stent [DES] to combine the proprietary endothelial progenitor cell […]
U.S. FDA Clears Abbott’s High Sensitivity Troponin-I Blood Test That Aids Doctors in Diagnosing Heart Attacks Faster and More Accurately
Newly cleared diagnostic test could help identify heart attacks several hours sooner than standard troponin tests and help improve diagnosis in women ABBOTT PARK, Ill., Sept. 25, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced that its ARCHITECT STAT High Sensitivity Troponin-I blood test has received clearance from the U.S. Food and Drug Administration […]
Colibri Heart Valve Receives a United States Patent Directed to a Replacement Heart Valve that Includes a Dry Valve Sutured to a Stent Member
BROOMFIELD, CO, Sept. 24, 2019 (GLOBE NEWSWIRE) — Colibri Heart Valve LLC, a privately held emerging medical device company, today announced that U.S. Patent No. 10,390,945 (“the ‘945 Patent”) was issued on August 27, 2019 by the United States Patent & Trademark Office with a priority date extending back to July […]
Shockwave Study Demonstrates Strong Safety and Procedural Success of Coronary IVL in Europe
TCT Presentation of DISRUPT CAD II EU Post-Market Study Confirms Promissory DISRUPT CAD I Results Data Published Simultaneously in Circulation: Cardiovascular Interventions SANTA CLARA, Calif., Sept. 25, 2019 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, unveiled […]
Vital Metrix Wins 2019 MedTech Breakthrough Awards Program
RESTON, Va.–(BUSINESS WIRE)–Vital Metrix, Inc. today announced that MedTech Breakthrough, an independent organization that recognizes the top companies and solutions in the global health and medical technology market, has selected the company as the winner of its “Best Biometric Sensor Solution” award in the 2019 MedTech Breakthrough Awards program. Vital Metrix, Inc. […]
Cardiovascular Systems, Inc. Announces FDA Approval of the Coronary ViperWire Advance® With Flex Tip
U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease 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, today announced […]
Attune Medical Expands IP Portfolio with Issuance of Additional Patent from USPTO and Acquisition of License from Stanford University
CHICAGO–(BUSINESS WIRE)–Chicago-based medical device firm Attune Medical has expanded its pioneering patent portfolio with two major advancements. The USPTO recently issued a broad method patent for Devices and Methods for Controlling Patient Temperature (US Patent number 10,363,162), which is the first patent in the Attune portfolio that specifically claims the […]



