Therapy Areas: Devices
Ambu and Cook Medical enter into agreement on distribution of disposable duodenoscopes in the US
20 May 2019 -

Ambu A/S (CPH:AMBUB), a developer, producer and marketer of life-saving equipment, announced on Friday that it has agreed on terms to enter into a partnership with Cook Medical (Cook) under which Cook will distribute Ambu's single-use, disposable duodenoscope in the US, following FDA clearance.

This duodenoscope is currently being developed by Ambu to help address infections caused by cross-contamination. Ambu is currently pursuing regulatory clearance from the US FDA for its single-use duodenoscope. These products are currently not available for sale in the US. Expected release for sale is before end of September 2020.

Since 2015, US regulatory authorities have increased their focus on endoscope cross-contamination, particularly reusable endoscopes for gastrointestinal use.

Reportedly, 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.

The company added that, together with Cook Medical, it plans to bring single-use endoscopes to patients undergoing ERCP procedures, to reduce the risk of serious cross-contaminations.

According to Ambu, 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.