FDA clears fully disposable duodenoscopeFebruary 5, 2020
The US FDA cleared for marketing Boston Scientific’s the EXALT Model D, the first fully disposable duodenoscope.
The single use duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
The FDA previously issued communications to health care facilities regarding risks associated with ineffective reprocessing of duodenoscopes that are used on multiple patients.
In August, the FDA released a safety communication recommending that duodenoscope manufacturers and health care facilities transition to duodenoscopes with partially or fully disposable designs, which can simplify or eliminate the need for reprocessing of certain components, therefore reducing or eliminating between-patient duodenoscope contamination.
The FDA previously cleared duodenoscopes with disposable endcap and elevator components.
The EXALT Model D single use duodenoscope was granted breakthrough device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development to expedite evidence generation and the agency’s review of the product.
The EXALT Model D was reviewed through the premarket clearance (510(k)) pathway.