Philips announces FDA clearance for its EchoNavigator live image-guidance tool


Royal Philips Electronics has announced that it has received 510(k) clearance from the FDA to market its EchoNavigator live image-guidance tool, which is designed to help interventional cardiologists and cardiac surgeons to perform minimally-invasive structural heart disease repairs by providing an integrated view of live X-ray and 3D ultrasound images.

Following the CE marking of EchoNavigator in Europe, a company press release reported, Philips will now be able to introduce the system globally. The first systems have already been installed in Europe and the USA.

According to the press release, Philips’ EchoNavigator was developed in response to a clear upward trend in the use of both X-ray imaging and 3D cardiac ultrasound during structural heart disease procedures.

Working in collaboration with partner hospitals in Europe and the US, Philips designed EchoNavigator to address the unique challenges associated with working with live X-ray and 3D ultrasound images simultaneously.

“Together with Philips, we set out to bring two separate medical imaging techniques together in a way that provides clear visual guidance”, said Professor John Carroll, interventional cardiologist, University of Colorado Hospital, Denver, USA. “A world-first, EchoNavigator is enabling us to use X-ray images combined with real-time 3D ultrasound images to navigate catheters and deploy implants in the right position in the heart, making such treatments more straightforward.”

The press release stated that Philips’ EchoNavigator will enable clinicians to perform procedures more efficiently by providing intelligently integrated X-ray and 3D ultrasound images into one intuitive and interactive view, as well as providing easy-to-use system navigation and better communication between the multidisciplinary team carrying out the procedure.

“We have learned that ideally two live imaging technologies are needed to guide catheter-based repairs to the heart and a multidisciplinary team is needed to perform it,” said Professor Roberto Corti, interventional cardiologist, University Hospital Zurich, Switzerland. “This adds to the complexity of such procedures. The development of a more sophisticated imaging technology such as EchoNavigator will definitely provide us with a better understanding of the complex structures of the heart and their repair.”