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
Uses Blue Light
The recommendation is conditional on minor changes to the labeling
and initiation of a postmarket surveillance study, said the manufacturer,
Xillix Technologies Corp. The device was developed at the British
Columbia Cancer Agency, Vancouver.
The Xillix LIFE (Lung Imaging Fluorescence Endoscope)-lung device
uses blue rather than white light to take advantage of natural
differences in fluorescence between normal and cancerous or precancerous
The natural fluorescence images are captured and intensified by
the LIFE camera, and the information is digitized and displayed
in real-time on a color monitor. The physician can then visually
identify areas from which to collect biopsies.
The FDA panel has recommended that the device be approved for
use in patients with known or suspected lung cancer to identify
suspicious tissue. The device has been shown to improve the physician's
ability to spot early lung cancer by 211% specifically in those
patients suspected of lung cancer, the company said.
Results from a multicenter clinical trial indicated a 171% improvement
in the physician's ability to identify and locate tissue suspicious
for moderate to severe dysplasia or worse using Xillix LIFE-Lung
as an adjunct to white light bronchoscopy, compared with conventional
white light bronchoscopy alone.