Industry Press Releases

Sep 16, 2020 | Industry Press Releases
Medtronic TYRX™ Absorbable Antibacterial Envelope Is Cost Effective for Patients at Increased Risk of Infections

DUBLIN, Sept. 16, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced new data from the landmark WRAP-IT study, showing the TYRX™ Absorbable Antibacterial Envelope (TYRX Envelope) is cost-effective for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs).

Sep 11, 2020 | Industry Press Releases
Avinger Receives FDA Clearance of Ocelaris Next Generation Image-guided CTO Crossing System

Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Ocelaris next-generation image-guided chronic total occlusion (CTO) crossing system.

Sep 9, 2020 | Industry Press Releases
Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation

Medtronic announced the U.S. Food and Drug Administration’s (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber causing […]

Aug 4, 2020 | Industry Press Releases
Abbott Announces Start of Study to Evaluate New Device to Treat Recurrent Atrial Fibrillation

ABBOTT PARK, Ill., Aug. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced first enrollments in the TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. The study will evaluate the performance of the investigational TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for […]

Jun 23, 2020 | Industry Press Releases
Philips receives FDA premarket approval for its HeartStart FR3 and HeartStart FRx automated external defibrillators

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 [1] and HeartStart FRx [2] automated external defibrillators (AEDs), and their supporting accessories, including batteries […]

Jun 16, 2020 | Industry Press Releases
BIOTRONIK Announces its Gradual Launch of His-Bundle Pacing Tools to Allow Physicians More Choices in Achieving Physiological Pacing

BIOTRONIK has today announced its commitment to giving physicians additional tools to pace in the His-Bundle, coinciding with the launch of its His-Bundle Pacing (HBP) tools in a limited number of centers starting now with a full launch later in 2020.

Jun 15, 2020 | Industry Press Releases
Medtronic Micra™ AV Receives CE Mark

Medtronic plc (NYSE:MDT) today announced it has received CE (Conformité Européenne) Mark for Micra™ AV Transcatheter Pacing System (TPS), the world’s smallest pacemaker with atrioventricular (AV) synchrony.

May 28, 2020 | Industry Press Releases
Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up

The HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief, which are parts of the HeartWare Ventricular Assist Device (HVAD) System, help the heart deliver blood to the rest of the body.

Apr 29, 2020 | Industry Press Releases
Abiomed Expands Product Portfolio with Acquisition of Cardiopulmonary Support Technology (ECMO) to Improve Outcomes for Patients

Abiomed (NASDAQ: ABMD), maker of the Impella heart pump, has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system that will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation, including patients suffering from cardiogenic shock or respiratory failure such as due to […]

Apr 16, 2020 | Industry Press Releases
VALBIOTIS Accelerates Its Pipeline Clinical Development in New Indications: Cardiovascular and Hepatic Steatosis Risk Reduction

VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/ SME eligible), a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces the acceleration of its pipeline clinical development, of plant-derived active substances, in new indications: cardiovascular and hepatic steatosis risk.

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