UMC-Ultrech ran a first-in-human feasibility study using the new technology to guide endovascular aortic repair (EVAR) and illiac or SFA PTA peripheral angioplasty procedures. hospitals hope to soon start using the system under and investigational device exemption in 2020. The technology now has European CE mark clearance and its being used at University Medical Center Utrecht (UMC) Ulrecht in The Netherlands, and at four other sites in Europe. First-in-Human Use of the FORS Cath Lab Imaging Technology If successful, FORS would be enable a radiation-free environment. Philips hopes to move beyond incremental innovation and instead develop this new concept as a breakthrough imaging technology. The FORS technology enables real-time 3-D visualization of devices inside the body without the need for fluoroscopy. Philips said it hopes to break through the current limitations of image guided therapy so clinicians can reduce their dependency on radiation-emitting fluoroscopy, while being able to see devices and anatomy more clearly inside patients during procedures. It uses overlays from pre-operative 3-D anatomical data from computed tomography (CT), magnetic resonance imaging (MRI), or intra-operative rotational angiographic X-ray imaging.
The FORS technology displays the full shape of devices in 3-D, in real-time and in distinctive colors, in multiple, user-controlled, unrestricted viewing angles and in context of the patient’s anatomy. The location of the wires is then superimposed on 3-D anatomical imaging. The technology is based on the concept of measuring strain in the optical fibers, using light reflected from density fluctuations in these fibers. FORS uses light traveling through hair-thin fiber optics inside special FORS enabled catheter and guidewires. The new Fiber Optic RealShape (FORS) technology creates real-time 3-D imaging of anatomy and devices inside the body using light, rather than X-rays. As cath lab procedures become longer and more complex, there has been rising concern over how operators can reduce X-ray radiation exposure for themselves, their staff and their patients. Philips is working on a prototype cath lab angiographic imaging system that might be able to replace the current X-ray fluoroscopy imaging systems used for interventional image guided procedures.