Boston Scientific Corporation has been cleared to market the EXALT Model D Single-Use Duodenoscope.
Duodenoscopes have many small working parts that can be difficult to clean. The device can trap contaminated tissue or fluid in its crevices and, if not thoroughly cleaned and disinfected, it can transmit infection-causing bacteria between patients.
The FDA previously cleared duodenoscopes with disposable endcap and elevator components. The EXALT Model D is the first fully disposable duodenoscope.
Source: FDA, Dec. 13, 2019