Industry Press Releases

Sep 23, 2019 | Industry Press Releases
LimFlow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients

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 […]

Sep 23, 2019 | Industry Press Releases
Medtronic Announces FDA Approval and U.S. Launch of Next-Generation Evolut™ PRO+ TAVR System for Treatment of Symptomatic Severe Aortic Stenosis Patients

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.

Sep 23, 2019 | Industry Press Releases
HeartFlow Announces FDA Clearance for HeartFlow Planner

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 […]

Aug 24, 2019 | Industry Press Releases
Miracor Medical Granted FDA Breakthrough Device Designation for the PiCSO Impulse System.

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.

Aug 24, 2019 | Industry Press Releases
Cook Medical Launches New 2.6 Fr CXI® Support Catheter.

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.

Jul 25, 2019 | Industry Press Releases
Abbott Receives U.S. Approval of Next-generation MitraClip G4

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.

Jul 25, 2019 | Industry Press Releases
BIOTRONIK Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III

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.

Jul 25, 2019 | Industry Press Releases
New Recall for Maquet/Datascope IABPs Due to Potential Battery Failure

The recall comes after reports of five patient deaths, which were not definitively linked to battery failure, since 2016

Jun 3, 2019 | Industry Press Releases
FDA Approves Impella 5.0 and Impella LD Extended Duration of Use to 14 Days for Cardiogenic Shock Derived from AMI or Cardiomyopathy

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.

Jun 3, 2019 | Industry Press Releases
Reprieve Cardiovascular Announces Late-Breaking Acute Heart Failure Clinical Trial Data

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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