FDA Clears Philips' HeartNavigator for Valve Replacement Procedures

December 21, 2011—Royal Philips Electronics (Andover, MA) announced the United States launch of the company's HeartNavigator interventional procedure planning and image guidance tool for use in transcatheter heart valve replacement procedures. The HeartNavigator was commercially introduced in Europe in the first quarter of 2011 and recently received 510(k) clearance from the US Food and Drug Administration.

According to the company, the technology merges preoperatively acquired three-dimensional (3D) computed tomography scans of the patient's heart with the live interventional x-ray views so that the interventionist can simultaneously see detailed 3D anatomy of the patient's heart together with the positioning of the catheter and placement and deployment of the artificial valve. The HeartNavigator is designed to increase the objectivity of procedure planning and to simplify the execution of the procedure.

“After the recent commercial introduction of transcatheter heart valves in the United States, 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,” commented Todd M. Dewey, MD. “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.”