Eric Chapman, medical devices Analyst at GlobalData, commented, “In December 2019, the U.S. Food and Drug Administration (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 Breakthrough Device Designation as it is the first and only single-use duodenoscope on the market approved in the U.S. 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 that the global market for duodenoscopes was worth over $360 million in 2019, with positive growth expected over the next 10 years.
Chapman continued: “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-sterilization, so that they can remain competitive.”
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 (fiber) duodenoscopes and flexible video duodenoscopes. Fiber 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.
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