Cook Medical to Distribute Danish Duodenoscope

Cook Medical, a family-owned medical device company with major operations in Winston-Salem, has formed a partnership with Ambu A/S of Denmark to distribute Ambu’s duodenoscope in the United States once the product has been approved by the U.S. Food and Drug Administration.

The companies declined to disclose terms of the collaboration.

A duodenoscope is a specialized endoscope – a flexible tube with a light

and camera attached to it – that allows doctors to see inside organs non-surgically so they can diagnose and treat problems. The scope is named for the duodenum, the first part of the small intestine, where digestive juices help process food into usable energy.

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

In April, the FDA issued a safety reminder to medical personnel who use duodenoscopes, urging them to adhere strictly to the manufacturer’s reprocessing and maintenance instructions, follow best practices, and report adverse event information to the FDA.

Re-use brings cross-contamination risks

“Duodenoscopes are complex instruments that contain many small working parts,” the FDA wrote. “If reprocessing instructions are not followed in every step of the process, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient transmission of infection.”

Ambu’s duodenoscope is a single-use, disposable instrument being developed to help prevent infections caused by cross-contamination.

“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.”

Duodenoscopes are used in endoscopic retrograde cholangiopancreatography procedures (ERCPs) to diagnose and treat conditions in the pancreatic and bile ducts including gallstones, scarring, cancer and leaks from trauma or surgery.

“This is a significant milestone toward our vision of a single-use ERCP solution,” said Juan Jose Gonzalez, chief executive officer 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.

Companies hope to start sales by October 2020

Ambu is currently pursuing regulatory clearance from the FDA for its duodenoscope. If it’s granted, sales are expected to begin by the end of September 2020, the companies said.

Ambu develops and markets medical products for visualization, anesthesia, patient monitoring and diagnostics. Headquartered near Copenhagen in Denmark, Ambu employs about 2,700 people in Europe, North America and the Asia Pacific. 

Cook Medical, founded in 1963 and based in Bloomington, Ind., develops medical devices, biologic materials and cellular therapies that eliminate the need for open surgery and help healthcare systems deliver better outcomes more efficiently. The company reports about $2 billion in annual sales.

Last year the company acquired an 850,000-square-foot production facility formerly owned by R.J. Reynolds at Winston-Salem’s Whitaker Park. Cook is transforming part of the building into a medical-device manufacturing facility that will house the company’s workforce of about 650 employees in Winston-Salem.

The company said it expects to add 50 new jobs there over the next 10 years.

Globally, Cook employs more than 12,000 people, including over 7,000 in the U.S. at facilities in Indiana, Illinois, Pennsylvania, North Carolina and California. 

In April, Forbes announced that Cook ranked 48th among 500 large companies in the America’s Best Employers of 2019 listing. This is the second consecutive year that Cook has been recognized with the honor.