FDA approves 160 cm endovascular navigation wire with 3D imaging guidance
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Key takeaways:
- The FDA approved a new 160 cm endovascular navigation wire.
- The navigation wire uses fiber optic technology to provide 3D colorized imaging guidance during complex vascular procedures.
Philips announced the FDA approved the 160 cm version of its endovascular navigation wire that uses fiber optic technology.
The navigation wire (LumiGuide) is designed utilize fiber optic technology (RealShape) to provide users with real-time, 3D, colorized imaging guidance to assist navigation of tortuous vessels. The device is designed to reduce use of fluoroscopy, which presents radiation risk for both patients and clinicians, and expedite treatment of complex cases such as aortic repair, according to a press release issued by the company.
The navigation wire is also designed to seamlessly integrate into the company’s image-guided therapy system (Azurion) for use alongside preoperative cross-sectional imaging.
The newly approved navigation wire is designed to provide more catheter loading possibilities than the company’s existing 120 cm guidewire, and enable wider use of 3D imaging guidance, according to the release.
To date, 1,000 patients have been treated with the company’s longer navigation wire since 2020.
“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," Atul Gupta, MD, interventional radiologist and chief medical officer for diagnosis and treatment at Philips, said in the release.
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