Dive Brief:

• Cook Medical struck a deal to distribute Ambu’s single-use, disposable duodenoscope in the U.S. after it gains FDA clearance, the companies announced over the weekend.

• The Ambu device is designed to eliminate the contamination risk associated with reusable endoscopes, which FDA linked to three deaths in a recent analysis.

• Ambu expects to begin selling the single-use device by the end of September 2020, setting Cook up to challenge Olympus, Fujifilm, Pentax and Boston Scientific for the duodenoscope market. Boston Scientific estimates the market could be worth $1 billion.

Dive Insight:

Ambu moved into the market for single-use endoscopy devices for accessing the airways around 10 years ago. The business is booming. Over the past 18 months, the number of Ambu endoscopes sold each quarter has increased by 49%, on average, giving the Danish device maker confidence it will sell 750,000 units this fiscal year.

And Cook, partnering with Ambu, wants to claim a slice of that opportunity. The alliance may give Cook a growth driver at a time when its own business is facing a headwind from FDA’s focus on paclitaxel-coated balloons and stents.​

The market is particularly primed for entry of single-use endoscopy devices given contamination risks associated with reusable endoscopy devices.

FDA has tried, with some success, to manage the risk of contamination from reusable endoscopes through the implementation of tougher safety measures. But a recent examination shows the threat remains. FDA’s analysis of 24 weeks of medical device reports identified three deaths, 45 infections and 159 reports of device contamination linked to inadequate reprocessing of duodenoscopes. An interim look at data from postmarket studies suggests 5% of devices are contaminated with “high concern” pathogens.

FDA ordered Olympus, Fujifilm and Pentax to run the post-marketing studies and hit them with warning letters when they failed to provide requested data. The agency wants to see manufacturers lessen or eliminate the contamination problem by developing easier-to-clean or single use products. The issue has also drawn congressional scrutiny.

Cook and Ambu are set to deliver the kind of single-use product the agency is calling for but will face competition for the single-use market. Boston Scientific began a clinical trial of its Exalt single-use duodenoscope late last year and is on course to win 510(k) clearance by the end of 2019. Given that physicians worldwide perform 1.3 million endoscopic retrograde cholangiopancreatography procedures each year. It's also unclear how quickly users will switch to single-use products.

In 2017, Ambu outlined plans to apply its knowledge of single-use endoscopes to the development of products for use in gastroenterology. Ambu is aiming to bring sterile single-use duodenoscopes, colonoscopes and gastroscopes to market by the end of September 2020. Its R&D drive contributed to a 19% increase in costs in the first half of this year but the market opportunities make the investment worthwhile, Ambu said.