FDA OKs HeartNavigator System from Philips

The U.S. Food and Drug Administration (FDA) has cleared a device made by Royal Philips Electronics that helps interventional cardiologists and cardiac surgeons to navigate during transcatheter aortic valve implantations. The product received 510(k) clearance last fall from the FDA.

The GPS-like HeartNavigator creates a three-dimensional image from previously acquired two-dimensional computed tomography datasets that are reconstructed and overlaid with live images to provide real-time 3D insights. With one click, the heart automatically is segmented to reveal anatomical structures and landmarks. Virtual device templates can be used to assess and select the best device size and projection for the patient’s individual anatomy. Positioning of the catheter is visualized in real-time together with the placement and deployment of the artificial valve, according to the company.

“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 Todd M. Dewey, M.D., Cardiothoracic Surgeon at Medical City Dallas Hospital in Dallas, Texas—the first American hospital to use the HeartNavigator in clinical practice. “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.”

The HeartNavigator was introduced early last year in Europe, where transcatheter heart valves are more of a mainstay. Such valves have only recently been commercially introduced in the United States; as a result, the adoption of minimally invasive heart valve replacement is still in its early stages. In Europe, where these valves have commercially been available since 2008, the market is more mature. Experts project that more than 13,000 minimally invasive valve replacements were performed in Europe in 2010, a number that has been growing annually at high double-digit growth rates. One physician estimated that nearly 900 transcatheter heart valve replacements have been performed at a clinic in Germany since the device became available in Europe.

“I plan all my cases with the HeartNavigator,” said H. Schröfel, senior cardiac surgeon at the Karlsruhe Heart Surgery Clinic in Karlsruhe, Germany. “I trust the measurements with HeartNavigator more than the measurements provided by the normal CT scan.”