Philips announces FDA approval for enhanced LumiGuide guidewire and marks the 1000th patient treated with its breakthrough 3D device guidance technology

Enhanced longer version of Philips LumiGuide Navigation Wire enables US clinicians to visualize a broader range of catheters
Internationally recognized vascular surgeon Carlos Timaran, MD, was the first to use the new LumiGuide wire to perform a complex aortic repair,
Procedure marks the world’s 1000th procedure assisted by Philips’ unique Fiber Optic RealShape (FORS) guidance technology

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced the introduction of the 160cm FDA approved version of its unique LumiGuide endovascular navigation wire. This enhanced LumiGuide guidewire, which utilizes the company’s breakthrough Fiber Optic RealShape (FORS) technology, was used for the first time on a patient by Professor and vascular surgeon Carlos Timaran, MD, an internationally recognized expert in advanced endovascular techniques. He used the technology 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.

"The new enhanced Philips LumiGuide navigation guidewire represents a significant leap forward in endovascular surgery, offering unprecedented 3D visualization and precision during complex procedures,” said Carlos Timaran, MD. “As the first to use this guidewire for a complex aortic repair, I experienced firsthand its potential to revolutionize how we approach minimally invasive vascular interventions. The patient who underwent this groundbreaking procedure is doing well, further validating the efficacy of this innovative technology.” 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 [1][2]. 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. The solution recently won the ‘Best of the Best’ 2024 Red Dot Design Award with the jury stating the innovation ‘not only revolutionizes instrument guidance in minimally-invasive procedures, but also aims to protect patients and medical staff’. [1] Eric J. Finnesgard, Jessica P. Simons, Douglas W. Jones, Caitlin M. Sorensen, Tammy T. Nguyen, Andres Schanzer. Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair, Journal of Vascular Surgery, November 12, 2022. DOI:https://doi.org/10.1016/j.jvs.2022.11.041. [2] Interim analysis report of FORS Learn Registry Bart Wessels; Philips, May 2023For further information, please contact:

Joost Maltha Philips External Relations Tel: +31 6 10 55 8116 Email: joost.maltha@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.

Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2023 sales of EUR 18.2 billion and employs approximately 68,700 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

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