Olympus has announced the FDA 510(k) clearance of Narrow Band Imaging (NBI) as enabling effective targeting of biopsies not seen under white light and improved visualization of tumor margins in nonmuscle-invasive bladder cancer (NMIBC).
Experts in urologic cancer say the approval is a significant advance that will ultimately improve the outcomes of patients with NMIBC.
Based on a weighted average, the aggregated FDA-reviewed studies (Int J Urol 2013; 20:602-9) show NBI has visualized NMIBC lesions in:
- 17% additional patients when compared with white light
- 24% additional tumors
- 28% additional carcinoma in situ (CIS).
This finding provides new treatment opportunities for urologists both in the office and in the operating room, according to a statement from Olympus. Additionally, it offers the potential for improved cost reduction and better patient outcomes resulting from earlier detection.
NBI enables effective targeting of biopsies not seen under white light without the use of dyes or drugs. It is not intended to replace histopathologic sampling as a means of diagnosis. NBI enhances visibility of vascular structures on the mucosal surface. Unlike white light, which uses all colors in the spectrum, NBI uses only blue and green, which are strongly absorbed by blood and appear darker than normal tissue.
NBI’s potential visualization of bladder cancer symptoms has been acknowledged by the medical community, but in 2013 a meta-analysis reviewed more than 30 studies on the topic, enough to submit to the FDA, according to Olympus.
“The detection of occult lesions in patients with de novo and recurrent bladder cancer results in markedly improved outcomes,” said Daniel Canter, MD, of the Urologic Institute of Southeastern Pennsylvania and Fox Chase Cancer Center. “An improved view into the underlying vascularity of the lining of the bladder means an improved ability to detect and treat not just the visible, obvious tumors but also the lesions that may have been missed with traditional white light cystoscopy only.
“This is something most urologists have known and would agree with, but it is now backed by the FDA, which should translate into improved patient care.”
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