Pentax launches scope with disposable cap to prevent infections

Pentax Medical announced it has launched a new duodenoscope with a disposable distal cap.

The C.A.P. HD Duodenoscope (ED34-i10T), approved by the FDA in September, is designed to improve access for cleaning and reprocessing to prevent infections during endoscopic retrograde cholangiopancreatography (ERCP) procedures. The product provides high definition imaging, improved clinical control, and aims to boost treatment and safety by improving “Clarity, Access and Performance.”

“We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in an FDA News Release at the time it was approved.

“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,” Hudson Garrett, PhD, MSN, MPH, global chief clinical officer for Pentax Medical, said in a company press release.

The product joins the company’s i10 Series of endoscopes, and its HD+ visualization, Pentax i-SCAN and OE Optical Enhancement technology are designed to provide detailed visualization of the mucosa to help endoscopists identify abnormal tissue and locate the papilla for cannulation. Its lightweight ergonomic design also provides improved ease of use, and its redesigned elevator mechanism enhances stability, per the press release.

“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,” Carlos Robles-Medranda, MD, Guayaquil, Instituto Ecuatoriano de Enfermedades Digestivas (IECED), University Hospital OMNI, Ecuador, said in the press release. “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.”

The FDA has been working with duodenoscope manufacturers to improve the safety of these devices since its initial safety communication in February 2015, which warned that their complex design may prevent effective cleaning and expose patients to serious infections like carbapenem-resistant Enterobacteriaceae (CRE).

Disclosures: Garrett is employed by Pentax. Healio Gastroenterology and Liver Disease was unable to confirm Robles-Medranda’s relevant financial disclosures at the time of publication.