Olympus receives FDA clearance for Narrow Band Imaging

Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today 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 boundaries in Non-Muscle-Invasive Bladder Cancer (NMIBC) patients.

Based on a weighted average, the aggregated FDA-reviewed studies show NBI has visualized NMIBC lesions in:

• 17 percent additional patients when compared with white light
• 24 percent additional tumors
• 28 percent additional carcinoma in situ (CIS or difficult-to-detect flat lesions)

This finding provides new treatment opportunities for urologists both in-office and in the O.R. Additionally, it offers the potential for improved cost reduction and better patient outcomes resulting from earlier detection.

NBI is the world's only patented endoscopic light technology that enables effective targeting of biopsies not seen under white light without the use of dyes or drugs. NBI is not intended to replace histopathological 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. Blue and green light are strongly absorbed by blood and appear darker than normal tissue. Blue light (415nm) highlights the shallow capillaries and green light (540nm) highlights deeper veins. 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 disparate studies on the topic, enough to submit to the FDA.

"The detection of occult lesions in patients with de novo and recurrent bladder cancer results in markedly improved outcomes," said Daniel Canter, M.D., Vice Chairman of the Urologic Institute of Southeastern Pennsylvania and the Department of Urology of the Einstein Healthcare Network and Associate Professor at The 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."

Bladder cancer is the sixth most common cancer in the United States, with the highest lifetime treatment costs per patient of all cancers. White light cystoscopy misses small papillary tumors or CIS at an estimated rate of 10-20 percent. Fifty-four percent of patients who go undiagnosed with CIS will progress to muscle invasive disease and require bladder removal (cystectomy) and a urinary diversion or neobladder. Ninety-six percent of patients diagnosed early will survive five years later. Bladder cancer is known to recur 50 percent of the time.