World's First Single-Use Duodenoscope Now Available

An innovative single-use duodenoscope eliminates reprocessing and repairs, allowing physicians to use a new, sterile device for every procedure.

The Boston Scientific (Natick, MA, USA) EXALT Model D single-use duodenoscope is designed for endoscopic examination of the duodenum and the performance of various procedures within it, including endoscopic retrograde cholangiopancreatography (ERCP). When connected to an EXALT Controller, the sterile, flexible duodenoscope provides imaging and illumination, four-way steerable navigation, lens wash, insufflation, suction, image capture initiation, and the delivery of various ancillary devices.

The EXALT Controller is an endoscopic video imaging system that receives video signals from the EXALT Model D, processes the incoming video signals, outputs video images to a video monitor, and outputs electrical signals that interface with external image capture systems. The EXALT Controller also controls the amount of light transmitted by the tip of the EXALT Model D Single-Use Duodenoscope to illuminate the area of interest within the anatomy.

“The EXALT Model D Duodenoscope was developed to support clinicians in their mission to deliver the highest quality patient care,” said Art Butcher, president of endoscopy at Boston Scientific and senior VP. “As a leading industry partner committed to advancing the care of pancreaticobiliary diseases for over 30 years, helping to ensure the integrity of ERCP is inherent in our mission to advance science for life and transform patient lives.”

“Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn't need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” said Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health (CDRH). “The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the United States each year.”

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