Category: Industry Press Releases

Edwards Receives Clearance For HemoSphere Platform With Intelligent Decision-Support Tools

December 29, 2018

IRVINE, Calif., Dec. 3, 2018 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced that the HemoSphere advanced hemodynamic monitoring platform has received U.S. Food and Drug Administration clearance for the Acumen suite of intelligent decision-support solutions.

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Medtronic receives FDA approval for Valiant Navion­­­™ thoracic stent graft system

November 30, 2018

Medtronic announced in October that it has received U.S. Food and Drug Administration (FDA) approval for the Valiant Navion™ thoracic stent graft system for the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).

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Abbott’s HeartMate 3 heart pump now FDA approved for advanced heart failure patients not eligible for a heart transplant.

November 29, 2018

Abbott announced that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives.

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One-Year Results from Real-World Study Showed Abbott’s Portico™ Transcatheter Aortic Valve Safely and Successfully Reduced Severe Aortic Stenosis

September 25, 2018

“Abbott (NYSE: ABT) today announced one-year results from a real-world, international, multicenter, 941-patient study of the company’s Portico™ transcatheter aortic valve replacement (TAVR) system in patients with symptomatic, severe aortic stenosis – a life-threatening narrowing of the heart’s aortic valve.”

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