Olympus has announced the market availability of the TJF-Q190V duodenoscope in the U.S. This new duodenoscope provides physicians with improved imaging and further enhanced therapeutic maneuverability for the treatment of patients requiring ERCP (endoscopic retrograde cholangiopancreatography), a highly challenging procedure.
The advanced visualization and more precise handling features of the duodenoscope include:
· An expanded vertical field of view that is 20% greater than the previous-generation duodenoscope, allowing for improved cannulation efficiency.
· Incorporation of High Force Transmission technology, enabling responsive maneuverability and clear tactile feedback for precise control during the procedure.
· Brighter Narrow Band Imaging (NBI) and dual guidewire locking at the distal end that enables reliable locking of 0.035-inch and 0.025-inch guidewires.
· The TJF-Q190V duodenoscope also includes safety features designed to further improve the efficiency of reprocessing including a disposable distal cover and manual flushing adapter. These safety enhancements respond to the FDA's call for duodenoscopes with disposable components that improve access to the elevator mechanism for ease of reprocessing.
Innovative infection prevention features:
· The sterile, clear, single-use distal cover is destroyed upon removal post-procedure, preventing the possibility of reuse.
· A proprietary distal-end flushing adaptor facilitates consistent and repeatable flushing of the distal end.
· New waterproof scope connector minimizes the risk of liquid ingress.
Olympus is offering trade-in values for older generation duodenoscopes to hasten the market transition to this new duodenoscope. In addition, Olympus is including in each sale a Premium Protection Plan that covers service inspections at every 100 uses or annually, whichever comes first. The plan also includes OEM parts and repair performed by OEM-trained technicians in an FDA-regulated facility, as well as protection for three years covering all maintenance and repair.
Olympus continues its close collaboration with the U.S. Food and Drug Administration (FDA) in support of the launch and ongoing support of the TJF-Q190V. Pursuant to the 522 Order from the FDA, Olympus is engaging in new post-market surveillance studies for the TJF-Q190V, including human factors and sampling & culturing. These studies will further the understanding of how Olympus can better prevent the risk of infection.
