FORS FIRST

Philips has developed the AltaTrack device, which provides a more intuitive visualization of both the anatomy and of the in-patient devices. The 3D real time visualization of the in-body instruments is obtained by employing the light-based Fiber Optic RealShape (FORS) technology. The FORS-enabled catheters and guidewires provide an X ray-free 3D visualization of the medical instrument in the patient’s body. The use of this technology for guidance in navigation during endovascular procedures can potentially lead to reduced radiation exposure, for patients and staff, reduced contrast dose and shorter procedure times. The AltaTrack device is a non-CE marked device and has never been tested in human subjects. This study is the First-in -Human (FIH) trial to evaluate the use of such a device.

The objective of this study is to assess performance of navigation in the arterial tree by using Fiber Optic RealShape (FORS)-enabled catheters and guidewires, thereby using FORS-based guidance as add-on to X ray imaging, in aortic and peripheral endovascular procedures. Performance, therefore, concerns two aspects: 1) performance of the FORS-enabled devices, and 2) performance of the FORS-based image guidance, as add on to X ray. Hence, performance of the Philips AltaTrack investigational device will be assessed through: 1) technical success of navigation in the arterial tree by using the FORS-enabled catheters and guidewires, and 2) qualitative judgement by the operator on the usefulness of FORS-based image guidance.

not applicable

-aortic endovascular intervention

-peripheral endovascular intervention