PENTAX Medical obtains CE mark for new duodenoscope
Endoscopic products developer PENTAX Medical has obtained CE-Mark for its Disposable Elevator Cap (DEC) Duodenoscope designed to prevent infection and improve reprocessing efficiency.
Developed for diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) procedures, the new device features advanced cleaning capabilities and high-definition (HD) imaging.
The single-use, sterile, distal end DEC cap is intended to address the elevated incidences of carbapenem-resistant Enterobacteriaceae (CRE) infections due to improper cleaning or disinfection of the duodenoscopes.
As well as preventing infection, the single-use product is expected to minimise the risk for cross-contamination and enable easy cleaning of the brush.
The DEC is said to aid in the decrease of reprocessing time and increase in operational efficiency, saving cost and allowing optimised procedures.
PENTAX Medical EMEA president Rainer Burkard said: “The new DEC Duodensocope is a world-first, combining high-quality imaging and therapeutic performance with pioneering patient safety features."
“Simplified reprocessing procedures also help to increase departmental productivity for confident reprocessing.”
With a combination of i-scan and i-scan OE, the duodenoscope facilitates detailed mucosal structure visualisation to detect and characterise lesions for identification of the minor papillae.
The device is designed in a way to allow easy cannulation and precise, controlled device positioning during ERCP procedures.
PENTAX is planning to present the infection control benefits of the DEC Duodenoscope at the EUS-ENDO congress to be held in Marseille, France, from 28-29 September.
Image: PENTAX Medical duodenoscope with disposable elevator cap. Photo: courtesy of PENTAX Medical.