PENTAX Medical Announces Launch Of First FDA-Cleared HD Duodenoscope With Disposable Distal Cap

PENTAX Medical, a developer endoscopic imaging tools, announced the U.S. launch of its C.A.P. HD Duodenoscope (ED34-i10T), the first FDA-cleared duodenoscope with a disposable distal cap. 

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP), which is a procedure that uses a combination of video endoscopy and fluoroscopic imaging to diagnose and treat conditions associated with the pancreaticobiliary system.

The C.A.P. HD Duodenoscope is designed to improve the standards of treatment and safety for both routine and advanced ERCP via improved Clarity, Access, and Performance. It features HD+ High Definition imaging, improved clinical control, as well as a detachable and disposable Distal Cap to improve access for cleaning and reprocessing.

“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, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a recent FDA News Release.

“PENTAX Medical is pleased to bring this new innovation to the market as part of our multi-tiered Medical Device Hygiene and Infection Control Strategy, specifically designed to improve the delivery of clinical care and overall infection control efforts by reprocessing technicians and nursing professionals,” said Dr. Hudson Garrett, Global Chief Clinical Officer for PENTAX Medical.

As the latest addition to the i10 Series of endoscopes, the new C.A.P. HD Duodenoscope continues the organization’s dedication to advanced imaging excellence with HD+ visualization, PENTAX i-SCAN and OE Optical Enhancement technology. These advances are designed to help endoscopists visualize the mucosa in detail, identify abnormal tissue, and locate the papilla for cannulation. Additionally, it offers the lightweight i10 Series Ergonomic Control Body for improved comfort and handling, as well as a redesigned elevator mechanism to enhance stability.

“In my practice, the use of the ED34-i10T [C.A.P. HD Duodenoscope] has helped improve the quality of procedures as its high definition image provides increased detailed visualization of the papilla by using advanced digital imaging technologies. This allows us to differentiate between normal papillae and adenomas,” said Dr. Carlos Robles-Medranda, Guayaquil, Instituto Ecuatoriano de Enfermedades Digestivas (IECED), University Hospital OMNI, Ecuador. “Additionally, the new design provides greater comfort during long procedures and requires less lever force to cannulate and maintain the required positioning, making this scope a must have tool for successful ERCP procedures.”

“PENTAX Medical is committed to advancing endoscopy with innovations that help improve clinical and economic outcomes and enhance patient and provider satisfaction,” said David Woods, President, PENTAX Medical, Americas. “With the C.A.P. HD Duodenoscope, we responded to a clinical need in a meaningful way.”