The FDA Nov. 15 approved the marketing of Montvale, N.J.-based Pentax of America's new duodenoscope design that reduces the chances of transmitting infection-causing bacteria between patients.
Duodenoscopes are used in more than half a million procedures each year to treat cancerous tumors, gallstones and other gastrointestinal conditions and are critical for lifesaving care for many patients in the U.S.
The device has many small parts that can be difficult to clean and can trap contaminated tissue or fluid in its crevices and transmit bacteria between patients if it's not properly cleaned and disinfected.
The scope, called the Pentax Medical Video, has a sterile, disposal elevator component that is meant to reduce the number of parts that need to be cleaned and disinfected between uses. The device is intended to provide visualization and access to the upper gastrointestinal tract to treat bile duct disorders and other upper GI problems.
Read the full news release here.