Manufactured by Boston Scientific, FDA Clears First Single-Use Duodenoscope

By MedTech Intelligence Staff
December 16, 2019


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, Market Access

U.S. physicians will finally be able to use a new, sterile duodenoscope on each patient, thanks to the FDA clearance of Boston Scientific’s EXALT Model D Single-Use Duodenoscope. The device is the first and only disposable duodenoscope available and was cleared via FDA’s Breakthrough Device Designation program.

“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 U.S. each year,” said CDRH Director Jeff Shuren, M.D. in an FDA news release. “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.”

The device is intended to provide visualization and access to the upper gastrointestinal tract for treatment of bile duct disorders and upper GI issues. It features a similar design to current reusable duodenoscopes to minimize the learning curve with physicians.

Watch this exclusive video — Cleaning Duodenoscopes: Are We Doing It Right?“With the EXALT Model D Duodenoscope, I can perform the same high-quality ERCP procedure with the added benefit of using a brand-new sterile device for each patient,” said Raman Muthusamy, M.D., medical director of endoscopy and professor of clinical medicine at the David Geffen School of Medicine at UCLA in a Boston Scientific press release. “I believe the development of this device is a significant advancement in the evolution of endoscopy.”

Boston Scientific plans to begin a limited U.S. market release of the duodenoscope during Q1 2020.