Philips announces FDA approval for enhanced LumiGuide guidewire and marks the 1000th patient treated with its breakthrough 3D device guidance technology
Philips has announced FDA approval for an enhanced 160cm version of its LumiGuide Navigation Wire, expanding the use of its Fiber Optic RealShape (FORS) technology in the US. This breakthrough allows clinicians to visualize a broader range of catheters in 3D and color during minimally-invasive surgeries, reducing reliance on X-ray imaging. The technology has now been used in 1000 procedures since 2020, with the latest milestone achieved by vascular surgeon Dr. Carlos Timaran during a complex aortic aneurysm repair. LumiGuide has shown to make procedures 37% faster and use 70% less X-ray imaging, significantly reducing radiation exposure for patients and medical staff.
Philips ha annunciato l'approvazione della FDA per una versione migliorata da 160 cm del suo LumiGuide Navigation Wire, ampliando l'uso della sua tecnologia Fiber Optic RealShape (FORS) negli Stati Uniti. Questa innovazione consente ai clinici di visualizzare un'ampia gamma di cateteri in 3D e a colori durante interventi chirurgici minimamente invasivi, riducendo la dipendenza dalle immagini a raggi X. La tecnologia è stata utilizzata in 1000 procedure dal 2020, con l'ultima pietra miliare raggiunta dal chirurgo vascolare Dr. Carlos Timaran durante una complessa riparazione di aneurisma aortico. LumiGuide ha dimostrato di rendere le procedure il 37% più veloci e di utilizzare il 70% in meno di immagini a raggi X, riducendo significativamente l'esposizione alle radiazioni per pazienti e personale medico.
Philips ha anunciado la aprobación de la FDA para una versión mejorada de 160 cm de su LumiGuide Navigation Wire, ampliando el uso de su tecnología Fiber Optic RealShape (FORS) en los EE. UU. Este avance permite a los clínicos visualizar un rango más amplio de catéteres en 3D y color durante cirugías mínimamente invasivas, reduciendo la dependencia de las imágenes de rayos X. La tecnología ha sido utilizada en 1000 procedimientos desde 2020, siendo el último hito alcanzado por el cirujano vascular Dr. Carlos Timaran durante una compleja reparación de aneurisma aórtico. LumiGuide ha demostrado hacer los procedimientos un 37% más rápidos y usar un 70% menos de imágenes de rayos X, reduciendo significativamente la exposición a la radiación para pacientes y personal médico.
Philips는 LumiGuide Navigation Wire의 160cm 버전 개선에 대한 FDA 승인을 발표했으며, 이를 통해 미국에서 Fiber Optic RealShape (FORS) 기술의 사용을 확대하고 있습니다. 이 혁신은 의사들이 최소 침습 수술 중 3D 및 컬러로 더 넓은 범위의 카테터를 시각화할 수 있게 하여 X-ray 영상에 대한 의존도를 줄이는 것을 가능하게 합니다. 이 기술은 2020년 이후 1000회 절차에서 사용되었으며, 마지막 이정표는 복잡한 대동맥류 수술을 진행한 혈관 외과의사 드. 카를로스 티마란에 의해 달성되었습니다. LumiGuide는 절차를 37% 더 빠르게 수행하고 X-ray 이미지를 70% 줄이는 데 기여하여 환자와 의료진의 방사선 노출을 상당히 줄이는 것으로 나타났습니다.
Philips a annoncé l'approbation de la FDA pour une version améliorée de 160 cm de son LumiGuide Navigation Wire, élargissant l'utilisation de sa technologie Fiber Optic RealShape (FORS) aux États-Unis. Cette innovation permet aux cliniciens de visualiser une plus large gamme de cathéters en 3D et en couleur lors de chirurgies minimales-invasives, réduisant ainsi la dépendance aux imageries par rayons X. La technologie a maintenant été utilisée dans 1000 procédures depuis 2020, le dernier jalon ayant été atteint par le chirurgien vasculaire Dr. Carlos Timaran lors d'une réparation complexe d'anévrisme aortique. LumiGuide a montré qu'il rend les procédures 37% plus rapides et utilise 70% moins d'images par rayons X, ce qui réduit considérablement l'exposition aux radiations pour les patients et le personnel médical.
Philips hat die Genehmigung der FDA für eine verbesserte 160 cm Version seines LumiGuide Navigation Wire bekannt gegeben, wodurch die Verwendung seiner Fiber Optic RealShape (FORS) Technologie in den USA erweitert wird. Dieser Durchbruch ermöglicht es klinischen Fachkräften, eine breitere Palette von Kathetern in 3D und Farbe während minimal-invasiver Chirurgie zu visualisieren und die Abhängigkeit von Röntgenbildern zu reduzieren. Die Technologie wurde seit 2020 in 1000 Verfahren eingesetzt, wobei die letzte Meilenstein von dem Gefäßchirurgen Dr. Carlos Timaran während einer komplexen Aorten-Anomalie-Reparatur erreicht wurde. LumiGuide hat gezeigt, dass die Verfahren 37% schneller und 70% weniger Röntgenbilder benötigt werden, was die Strahlenbelastung für Patienten und medizinisches Personal erheblich reduziert.
- FDA approval for enhanced 160cm LumiGuide Navigation Wire
- Expansion of FORS technology use in US healthcare centers
- 37% faster procedure times with LumiGuide technology
- 70% reduction in X-ray imaging during procedures
- Milestone of 1000 procedures using FORS technology reached
- Integration with Philips' Image Guided Therapy System - Azurion
- Won 'Best of the Best' 2024 Red Dot Design Award
- None.
Insights
Philips' enhanced LumiGuide Navigation Wire represents a significant advancement in endovascular surgery. The FDA approval of the 160cm version expands its applicability, allowing visualization of a broader range of catheters. This FORS technology provides 3D color visualization of guidewires and catheters in real-time, offering a substantial improvement over traditional 2D grayscale X-ray fluoroscopy.
The technology's ability to reduce procedure times by
As a vascular surgeon, I find the LumiGuide's capabilities in complex aortic repairs particularly impressive. The ability to visualize devices in 3D from any angle, including 'virtual biplane' images, is a game-changer for navigating tortuous vessels. This technology could significantly improve precision in challenging procedures like aortic aneurysm repairs.
The 1000th patient milestone and successful use by Dr. Timaran in a complex case demonstrate growing clinical acceptance. However, it's important to note that while this technology shows promise, long-term outcomes and cost-effectiveness studies will be necessary to fully establish its place in standard vascular surgery practice. The potential for reduced radiation exposure is a significant benefit, but training and learning curves for adopting this new technology should be considered.
From a market perspective, Philips' LumiGuide represents a strategic move in the competitive medical imaging and guided therapy sector. The FDA approval and expanded capabilities of the 160cm wire version could drive adoption in the U.S. market, potentially boosting Philips' market share in endovascular devices.
The technology's Red Dot Design Award adds to its market appeal, potentially influencing purchasing decisions. However, the financial impact will depend on pricing strategy, reimbursement policies and the speed of adoption by healthcare providers. While the technology shows promise, investors should monitor real-world data on clinical outcomes and cost-effectiveness, as these will be important for widespread adoption and long-term market success. The integration with Philips' existing Azurion system could provide a competitive edge and encourage loyalty within their ecosystem.
- 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
“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 2023
For 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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