Boston Scientific has secured the US Food and Drug Administration (FDA) 510(k) approval for its single-use duodenoscope EXALT Model D, intended for endoscopic retrograde cholangiopancreatography (ERCP) procedures.

According to Boston Scientific, its EXALT Model D is the first and only FDA approved single-use (disposable) duodenoscope available and the FDA has granted the breakthrough device designation for the device.

Boston Scientific endoscopy senior vice president and president Art Butcher said: “The EXALT Model D Duodenoscope was developed to support clinicians in their mission to deliver the highest quality patient care.

“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. This device, which was granted Breakthrough Device Designation by the FDA, builds on our legacy of delivering meaningful innovation that improves clinical outcomes.”

EXALT Model D is an alternative to traditional reusable duodenoscopes

Reusable duodenoscopes are subjected to severe disinfection process after each use, to ensure the safety and effectiveness of the procedures. However, infections have been found transmitted between patients through contaminated devices in few cases.

The company claimed that it has developed the device as an alternative to reusable duodenoscopes, eliminating the need for duodenoscope reprocessing and repairs, and allowing physicians to use a new, sterile device for every procedure.

Its EXALT Model D Duodenoscope is designed based on the design of standard reusable duodenoscopes, offering reduced learning curve experience for physicians while adopting the technology.

The company has voluntarily conducted a series of case studies using its EXALT Model D Duodenoscope, which demonstrated that expert endoscopists are enabled to complete complex ERCPs using the single-use duodenoscope.

UCLA David Geffen School of Medicine professor Raman Muthusamy said: “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. I believe the development of this device is a significant advancement in the evolution of endoscopy.”