Updated Dec. 23, 2011, to correct that the HeartNavigator is inserted through a small incision in the leg, not in the chest.
Philips Healthcare (NYSE:PHG) landed FDA clearance for its HeartNavigator heart valve replacement system.
Medical City Dallas Hospital became the first U.S. hospital to use the system, which was launched in Europe in the first quarter of this year.
The HeartNavigator system allows physicians perform heart valve replacements without the need for open-heart surgery by using a catheter.
"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," Dallas Hospital surgeon Dr. Todd Dewey said in prepared remarks. "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."
A physician inserts the catheter via a small incision in the leg and guides it to the heart using x-ray systems.
Adoption of catheter-based valve replacement procedures are in their infancy, as the artificial valves necessary for these procedures were only recently made commercially available in the U.S., according to Philips.
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