FDA grants 510(k) clearance for Olympus’s Narrow Band Imaging

16 December 2014 (Last Updated December 16th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Olympus's Narrow Band Imaging (NBI), a patented endoscopic light technology that enables effective targeting of biopsies without using dyes or drugs.

NBI

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Olympus's Narrow Band Imaging (NBI), a patented endoscopic light technology that enables effective targeting of biopsies without using dyes or drugs.

The company claims NBI allows effective targeting of biopsies not seen under white light and improved visualisation of tumour boundaries in non-muscle-invasive bladder cancer (NMIBC) patients.

Based on a weighted average, the aggregated FDA reviewed studies show NBI visualised NMIBC lesions in 17% additional patients, compared with white light, 24% additional tumours and 28% additional carcinoma in situ (CIS).

NBI uses only blue and green, unlike white light, which uses all colours in the spectrum and it improves visibility of vascular structures on the mucosal surface.

Einstein Healthcare Network Urologic Institute of Southeastern Pennsylvania and the Department of Urology vice chairman Daniel Canter said: "The detection of occult lesions in patients with de novo and recurrent bladder cancer results in markedly improved outcomes.

"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 tumours 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."

"NBI uses only blue and green, unlike white light, which uses all colours in the spectrum and it improves visibility of vascular structures on the mucosal surface."

According to the company, NBI can be used for NMIBC in the office, clinic for cystoscopy (diagnosis) and in the operating room or ambulatory surgical centre for resection (tumour removal or transurethral resection of bladder tumour [TURBT]).

Olympus Corporation of the Americas Medical Systems Group sales, marketing and shared services executive vice-president Richard Reynolds said: "We are excited to offer NBI to the urologic community and share this new development with primary care physicians who can refer patients to urologists using NBI.

"We believe that NBI has the potential to revolutionise how bladder cancer is detected and treated, helping our customers meet the triple aim of healthcare reform by improving quality of care, decreasing costs and enhancing patient satisfaction."

NBI holds clinical applications throughout the anatomy including gastroenterology, pulmonary and rhino laryngology (ENT).

The company received clearance from the FDA for the screening and surveillance of Barrett's esophagus, and is currently exploring other claims for NBI in gynaecology and general surgery.


Image: NBI visualised NMIBC lesions in an additional 17% of patients, compared to white light. Photo: courtesy of PRNewswire / Olympus.