Cook Medical and Ambu A/S have agreed on terms to enter into a partnership under which Cook will distribute Ambu’s single-use, disposable duodenoscope in the U.S., following FDA clearance. The scope is currently being developed by Ambu to help address infections caused by cross-contamination*. Since 2015, U.S. regulatory authorities have increased their focus on endoscope cross-contamination, particularly reusable endoscopes for gastrointestinal use.
The use of reusable endoscopes can 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.
“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,” said Barry Slowey, Vice President of Cook Medical’s Endoscopy business. “Our collaboration with Ambu is based on a shared goal to enhance patient safety.”
"This is a significant milestone towards our vision of a single-use ERCP solution,” said Juan Jose Gonzalez, CEO of Ambu. “Together with Cook Medical we plan to bring single-use endoscopes to patients undergoing ERCP procedures, to reduce the risk of serious cross-contaminations."
No further details about the agreement will be disclosed at this time, but the agreement is not expected to have any impact on the outlook for Ambu concerning growth, earnings or free cash flows towards September 2020 as put forth in connection to the earnings relase for H1 on May 1 2019.
*Ambu is currently pursuing regulatory clearance from the U.S. FDA for its single-use duodenoscope. These products are currently not available for sale in the U.S. Expected release for sale is before end of September 2020.
Media contact, Cook Medical
Christa Curtis
Global Director, Corporate Marketing and Communications, Cook Medical
Christa.Curtis@CookMedical.com
812.339.2235 ext. 10-5352 (office)
812.929.0208 (mobile)
Media contact, Ambu A/S
Morten Huse Eikrem-Jeppesen
PressConnect
morten@pressconnect.dk
+45 5385 0770 (mobile)
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