The Food and Drug Administration on Wednesday approved Pentax of America's new duodenoscope, which features a disposable distal cap to improve device cleaning and reprocessing.
Duodenoscopes are intended to help clinicians visualize and access the upper gastrointestinal tract to treat bile duct disorders and other upper GI conditions. The Pentax ED34-i10T is the first duodenoscope with a disposable distal cap to earn FDA approval.
"We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices," said William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health. "Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients."