Cook Medical, a family-owned medical device company that develops less invasive devices and Ambu, a developer and producer of diagnostic and life-supporting devices, have entered into a partnership for marketing single-use, disposable duodenoscope in the US.
The two companies have signed the agreements under which, Cook would distribute Ambu’s single-use, disposable duodenoscope in the US markets after receiving of FDA clearance.
The single-use duodenoscope is currently not available for sale in the US and is expected to be released for sale before end of September 2020. Ambu is currently pursuing regulatory clearance from the US FDA.
Ambu CEO Juan Jose Gonzalez said: “This is a significant milestone towards our vision of a single-use ERCP solution. “Together with Cook Medical we plan to bring single-use endoscopes to patients undergoing ERCP procedures, to reduce the risk of serious cross-contaminations.”
Since 2015, the US regulatory authorities have increased their focus on endoscope cross-contamination, particularly reusable endoscopes for gastrointestinal use.
The use of reusable endoscopes could pose a contamination risk to patients because the devices are difficult to reprocess between uses. Alternatively, single-use scopes could have a significant impact on device-related infections and improve hospital workflows because they do not require cleaning or repair.
Under the collaboration, Ambu is currently developing the scope to help address infections caused by cross-contamination. Additional details regarding the agreement are not disclosed.
Cook Medical Endoscopy business vice president Barry Slowey said: “Our mission is to improve patient care and we were looking for a solution to reduce the risk of infections associated with the use of reusable endoscopes. Our collaboration with Ambu is based on a shared goal to enhance patient safety.”
In November 2018, Cook Medical collaborated with Taewoong Medical on distributing a selection of Taewoong’s stents in the US, expand patient treatment options.
The distribution partnership also includes the Niti-S Through the Scope (TTS) esophageal Stent, the product of the South Korean company’s Niti-S Self-Expandable line of metal gastrointestinal (GI) stents.
The Niti-S TTS Esophageal Stent is designed for use in certain types of esophageal strictures caused by malignant tumors.