Philips Nets FDA Clearance for Longer LumiGuide Endovascular Guidewire

Royal Philips announced the introduction of the 160cm FDA approved version of its LumiGuide endovascular navigation wire. This enhanced LumiGuide guidewire, which utilizes the company’s Fiber Optic RealShape (FORS) technology, was used for the first time on a US patient during a complex aortic aneurism repair operation, marking the 1000th patient treated milestone using FORS technology since first clinical use of the technology in 2020. The introduction of a longer FORS-enabled LumiGuide Navigation Wire enables US clinicians to visualize a broader range of catheters and expands usage of this technology to patients in America treated in centers equipped with LumiGuide.

Usually during minimally-invasive surgeries, doctors have to rely on live X-ray imaging (fluoroscopy) to help them manipulate interventional devices such as catheters inside the patient’s body. But real-time X-ray fluoroscopy comes with radiation risks for both patients and physicians and only provides grayscale, 2D images of these devices. LumiGuide –powered by Philips’ unique FORS technology – changes the game by allowing doctors to see their guidewires and catheters in 3D and color as they manipulate them inside the patient's body, from any angle, in real-time, and with minimal radiation. Philips’ FORS technology simplifies navigation in tortuous vessels (blood vessels that are twisted or winding). Using this advanced technology, complex cases such as aortic repair procedures can be done 37% faster and use 70% less X-ray imaging during the process. Providing greater reach and enhanced catheter loading possibilities than the company’s existing 120cm (47 inch) guidewire, Philips’ new 160cm (63 inch) LumiGuide wire enables US physicians to experience 3D device guidance with more catheters than before, enabling use of the technology for more patients and procedures.

 “LumiGuide unlocks the color visualization of wires, catheters, and patient anatomies in 3D from any angle, including simultaneous angles to generate ‘virtual biplane’ images. Combined with device navigation viewed from angles physically unachievable using conventional C-arm systems, it has already been shown to improve workflows, reduce procedure times, and decrease patient and staff radiation dose," said Dr Atul Gupta, Chief Medical Officer for Diagnosis and Treatment at Philips and a practicing interventional radiologist.

Philips LumiGuide integrates seamlessly into the company’s Image Guided Therapy System – Azurion – allowing its use alongside pre-operative cross-sectional imaging.