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A tecnologia da imagem latente de Olympus para biopsies da bexiga começa o assentimento do FDA
Olympus announced yesterday that its Narrow Band Imaging (NBI) technology received 510(k) clearance from the FDA. NBI will allow physicians to remove small tumors in their offices, which will prevent costly operating room procedures if the tumor is spotted early enough.
The company claims that it's the only patented endoscopic light technology that requires no dyes or drugs to effectively target bladder biopsies that were previously not seen under white light.
Blood absorbs NBI's blue and green light more so it makes the tissue appear darker and allows the surgeon to see vascular structures on the mucosal surface more clearly. The blue light is used to highlight the shallow capillaries and the green light highlights deeper veins.
FDA-reviewed studies found that NBI can visualize 17 percent more Non-Muscle-Invasive Bladder Cancer lesions, 24 percent additional tumors and 28 percent additional carcinoma in situ, which are flat lesions that are hard to detect, than white light.
Bladder cancer is the sixth most prevalent cancer in the U.S., according to the Surveillance, Epidemiology, and End Results Program. In addition, a study published in the World Journal of Urology in 2009 found that it's associated with the highest lifetime treatment costs per patient.
In addition to physicians' offices, NBI can also be used in the operating room or ambulatory surgical center to improve the removal of a tumor. Before removal, the surgeon uses it to target the biopsy and then during removal it improves visibility of tumor margins.
Olympus also developed a NBI urology application for physicians to be used on mobile devices. It includes the technology overview, 28 clinical case images, comparisons of white light and NBI images, an interactive slider and an option to email a case summary to a consulting physician, staff member or patient.
Other than urology, NBI also has implications for gastroenterology and pulmonary and rhinolaryngology. To date, Olympus has FDA approval to screen and monitor Barrett's esophagus, and they are investigating other applications for NBI in gynecology and general surgery.
