Koninklijke Philips N.V.
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Publicatie datum
21 dec 2011 - 10:01
Statutaire naam
Koninklijke Philips N.V.
Titel
Philips announces FDA clearance and first commercial installation of its HeartNavigator interventional tool in the United States
Bericht
Advanced imaging-based ‘HeartNavigator’ tool is designed to support heart valve replacement without open heart surgery
Andover, MS – Royal Philips Electronics (NYSE: PHG, AEX: PHI) today announced that Medical City Dallas Hospital (Dallas, Texas, U.S.) is the first hospital in the U.S. to use Philips’ innovative HeartNavigator interventional tool in clinical practice. HeartNavigator is a new procedure planning and image guidance tool to help interventional cardiologists and cardiac surgeons perform minimally invasive heart valve replacements. Developed in cooperation with partner hospitals around the world, HeartNavigator is designed to increase the objectivity of the procedure planning and to simplify the procedure itself. By doing so, it aims to reduce the burden on patients and improve patient care.
HeartNavigator was commercially introduced in Europe in the first quarter of 2011 and recently received 510(k) clearance from the Food and Drug Administration (FDA). As a pioneer and market leader in interventional cardiology, Philips is one of the first companies to offer a comprehensive portfolio in the U.S. that includes hybrid operating room solutions and imaging solutions plus advanced interventional tools that work smoothly in sync with them.
“After the recent commercial introduction of transcatheter heart valves in the U.S., we are now able to offer heart valve implantations to a group of patients for whom the risks associated with open heart surgery are too high,” said Dr. Todd M. Dewey, MD, Cardiothoracic Surgeon at Medical City Dallas Hospital, Dallas, Texas, U.S. “The implantation of a heart valve via a catheter has the advantage of being minimally invasive, but it demands high-quality imaging and precise navigation to ensure accurate positioning. HeartNavigator gives us a much better view of the procedure, which aids us in the preparation of the procedure as well as the execution.”
Datum laatste update: 01 september 2024