www.fdanews.com/articles/195182-boston-scientifics-disposable-duodenoscope-cleared
Boston Scientific’s Disposable Duodenoscope Cleared
December 17, 2019
The FDA has cleared Boston Scientific’s disposable Exalt Model D for endoscopic retrograde cholangiopancreatography (ERCP) procedures.
The device was developed to serve as another option for physicians who do not wish to use standard reusable duodenoscopes, which require maintenance and a demanding sterilization process.
The Model D’s single-use design means the device does not need to undergo repairs or reprocessing and ensures a new, sterile device is used in every procedure.