Coronary/Structural Heart

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 […]

Highest Court in Germany Affirms Strength of Abiomed’s Patents

DANVERS, Mass.–(BUSINESS WIRE)–The highest court in Germany, the Federal Court of Justice, recently ruled in favor of Abiomed (NASDAQ: ABMD) in a patent challenge filed by Thoratec in 2015 and validated the strengths of Abiomed’s Impella-related patents. These patents are also the subject of a separate patent infringement action Abiomed […]

Medtronic Announces FDA Approval and U.S. Launch of Next-Generation Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients

Improved Functionality Across Four Valve Sizes and Lowest Delivery Profile on the Market, the Evolut PRO+ TAVR System Launches in U.S. as TAVR Patient Population Grows DUBLIN, Sept. 23, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration […]

Cardax Announces Interim Results from CHASE Clinical Trial

Pre-Specified Interim Review Demonstrated Beneficial Changes in Markers of Cardiovascular Health – CRP, LDL, total cholesterol, triglycerides, oxidized LDL, and blood pressure reduced – Interim results support excellent safety profile – Enrollment continues HONOLULU, Sept. 23, 2019 /PRNewswire/ — Cardax, Inc. (OTCQB: CDXI) today announced results from the pre-specified interim review of its […]