Industry Press Releases
PARIS–(BUSINESS WIRE)–LimFlow SA, a pioneer in the development of minimally-invasive technology for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD), announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption for the PROMISE II pivotal study of the LimFlow Percutaneous Deep Vein […]
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 (FDA) approval and U.S. launch of the Evolut™ PRO+ TAVR System – a new-generation Medtronic TAVR system that builds off the proven self-expanding, supra-annular Evolut TAVR platform.
REDWOOD CITY, Calif. – September 12, 2019 – HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore […]
AWANS, Belgium–(BUSINESS WIRE)–Miracor Medical SA (Miracor Medical) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients.
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical recently released the second generation of the 2.6 Fr CXI Support Catheter with platinum-iridium marker bands. The CXI catheter is used in small-vessel anatomy or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
The latest approval for the fourth-generation MitraClip device, MitraClip G4, puts new enhancements into the hands of physicians across the U.S. by delivering an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time to offer doctors further options when treating mitral valve disease.
LAKE OSWEGO, Ore., July 8, 2019 – BIOTRONIK today announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment.
The recall comes after reports of five patient deaths, which were not definitively linked to battery failure, since 2016
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ:ABMD) announces the U.S. FDA has approved the expansion of the Impella 5.0 and Impella LD PMA labeling for the treatment of cardiogenic shock.
MILFORD, Mass.–(BUSINESS WIRE)–Reprieve Cardiovascular™, a pioneering medical device company focused on improving outcomes for patients suffering from Acute Decompensated Heart Failure (ADHF), today announced the results of two non-randomized, prospective clinical trials in patients hospitalized with Acute Heart Failure (AHF).
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