Philips Healthcare announced this week that the U.S. Food and Drug Administration has granted 510 (k) clearance for a first-of-a-kind technology from the company intended to help interventional cardiologists perform novel therapeutic treatments for structural heart disease repairs.

Philips' EchoNavigator, an image-guidance tool, combines live X-ray and 3-D ultrasound images so that the team of doctors can navigate structures of the heart using both modalities.

"The combination of X-ray and ultrasound images — what we call registration — is very unique and allows us as clinicians to have visualization of the person's heart with these two modalities," Dr. John Carroll, interventional cardiologist at the University of Colorado Hospital in Denver, told DOTmed News. Carroll has also worked closely with Philips' research team for the past four years as a key collaborator on the technology.


Over the last five years, new structural heart disease treatments have emerged, including transcatheter aortic valve implantation (TAVI), mitral heart valve repair, left atrial appendage closure and others. In fact, these procedures are one of the biggest growth areas for cardiac surgeons and interventional cardiologists. According to Carroll, minimally invasive procedures are ideal for patients who are too at-risk for surgery, and they are attractive to many because recovery is quicker and better.

Incorporating feedback from doctors like Carroll, Philips picked up on what would help doctors most when using live X-ray and 3-D images simultaneously to perform structural heart disease treatments.

"The target of the therapy is usually a structure in the heart that's hard to see on X-ray images because it's soft tissue valves," said Carroll. Furthermore, X-ray contrast injections can't be used to enhance the images due to the large volume of agent that would be required. For these reasons and more, ultrasound has become the second major imaging modality added in the space to allow the performance of these novel treatments, according to Carroll.

In addition to integrating the ultrasound technology into the procedure room, the EchoNavigator application fuses the ultrasound and X-ray images together on the computer workstation. When they are projected onto the procedure room screen for everyone to see, additional tools help the clinicians use the images more efficiently. One can overcome some of the challenges of working with images interactively through labeling or marking structures on the real-time images. This not only provides better navigation, but also helps the whole team understand what is being imaged.

"This is a tool set to make standard medical images more usable to complete the tasks that are involved in completing one of the novel therapeutic interactions," said Carroll.

Philips introduced a portable ultrasound system last year, the CX50 xMATRIX, which incorporates Live 3-D TEE technology. A Philips spokesperson told DOTmed News that the EchoNavigator can only be used with Philips ultrasound and X-ray equipment.

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