RICHMOND, BC--The FDA's Ear, Nose, and Throat Device Advisory Panel has voted unanimously in favor of recommending a premarket approval (PMA) application for Xillix LIFE-Lung, a fluorescence imaging system that helps identify early lung cancer (see figure ).
RICHMOND, BC--The FDA's Ear, Nose, and Throat Device AdvisoryPanel has voted unanimously in favor of recommending a premarketapproval (PMA) application for Xillix LIFE-Lung, a fluorescenceimaging system that helps identify early lung cancer (see figure).
The recommendation is conditional on minor changes to the labelingand initiation of a postmarket surveillance study, said the manufacturer,Xillix Technologies Corp. The device was developed at the BritishColumbia Cancer Agency, Vancouver.
The Xillix LIFE (Lung Imaging Fluorescence Endoscope)-lung deviceuses blue rather than white light to take advantage of naturaldifferences in fluorescence between normal and cancerous or precanceroustissues.
The natural fluorescence images are captured and intensified bythe LIFE camera, and the information is digitized and displayedin real-time on a color monitor. The physician can then visuallyidentify areas from which to collect biopsies.
The FDA panel has recommended that the device be approved foruse in patients with known or suspected lung cancer to identifysuspicious tissue. The device has been shown to improve the physician'sability to spot early lung cancer by 211% specifically in thosepatients suspected of lung cancer, the company said.
Results from a multicenter clinical trial indicated a 171% improvementin the physician's ability to identify and locate tissue suspiciousfor moderate to severe dysplasia or worse using Xillix LIFE-Lungas an adjunct to white light bronchoscopy, compared with conventionalwhite light bronchoscopy alone.