FDA greenlights first duodenoscope with disposable distal cap

por John R. Fischer, Senior Reporter | September 27, 2017
PENTAX Medical ED34-i10T model
PENTAX Medical is set to release the first duodenoscope with a disposable distal cap into the U.S. market in the near future, following the FDA’s recent approval of the device.

The ED34-i10T model duodenoscope will provide visualization and access to physicians examining the upper gastrointestinal (GI) tract for treating bile duct disorders and other upper GI problems, with the addition of the cap reducing the risk of infections being transferred from one patient to another.

“The disposable distal cap design represents a significant advancement in infection control,” Mariano Franco, associate director of marketing communications at PENTAX Medical, told HCB News. “We continue to collaborate with the health care community, FDA and other agencies to develop new advancements in flexible endoscopy, with the objective of providing the highest quality technology, training, and service to our customers.”

The traditional, flexible, lighted duodenoscope consists of small working parts that are difficult to clean. If not sterilized thoroughly, such devices can collect and trap contaminated tissue and fluids within their crevices, thereby increasing the risk of infections being transferred between patients.

The ED34-i10T includes a single-use, detachable and disposable distal cap, and offers easier user interface, improved ergonomics, enhanced image quality and reduced length.

PENTAX Medical also put its Slim Linear Ultrasound Endoscope on the market in August.

The date for the release for the duodenoscope has not yet been disclosed.

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