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First single-use duodenoscope approved by the FDA

Duodenoscopes are side-viewing endoscopes primarily designed for endoscopic retrograde cholangiopancreatography (ERCP) for visualization of the interior of the duodenum.

Traditionally used duodenoscopes include flexible non-video (fibre) duodenoscopes and flexible video duodenoscopes. Fibre duodenoscopes have a flexible insertion tube with an eyepiece for visualization. They may or may not have an add-on camera to take images of the target location. Flexible video duodenoscopes have a flexible insertion tube with video recording functionality, which uses a charge-coupled device to display magnified images on a video screen. While fibre duodenoscopes were once used most, flexible video duodenoscopes now dominate the market, with the non-video scopes mostly becoming obsolete. Currently, Olympus Corporation is the market leader for duodenoscopes, with companies, including Karl Storz, Fujifilm Holding, and Pentax having smaller market shares.

In December 2019, the FDA announced that it had approved the first fully disposable duodenoscope, manufactured by Boston Scientific. The scope, referred to as the EXALT Model D Single-Use Duodenoscope, was given the Breakthrough Device Designation, as it is the first and only single-use duodenoscope on the market approved in the US. The Breakthrough Devices Program is used to distinguish new medical devices that provide significant advancements in medicine and diagnostics. The EXALT Single-Use Duodenoscope will be safer to use since this device will not need to be reprocessed. Traditional duodenoscopes are used on multiple patients and need to be sterilized between uses. Improper sterilization can result in the spread of infection with detrimental outcomes to patients. This is especially true for duodenoscopes because they have many small parts that are difficult to clean.

GlobalData estimates the global market for duodenoscopes in 2019 to have been worth over $360m with positive growth over the next ten years. The introduction of Boston Scientific’s EXALT Single-Use Duodenoscope in 2020 is expected to act as a major disruptor to the duodenoscope market, resulting in a rapid rise of Boston Scientific’s market share. Companies that manufacture duodenoscopes should expedite research and development related to the ease of re-sterilisation so that they can remain competitive.

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