The GI endoscopy space has been strongly affected by the fact that duodenoscopes contaminated with the "superbug" carbapenem-resistant Enterobacteriaceae were linked to numerous deaths in the US in 2015 and 2016. Subsequent FDA-mandated postmarket surveillance studies found higher than anticipated contamination rates in reprocessed duodenoscopes, caused largely by the presence of reusable components—namely fixed endcaps—that are difficult to sterilize or that render proper sterilization of other parts challenging.

As a result, in August 2019, the FDA issued a recommendation for hospitals and endoscopy facilities to begin transitioning toward the use of disposable endcap duodenoscopes and those that contain disposable components that increase the ease of reprocessing.

The complications surrounding reusable duodenoscopes have spurred a flurry of innovation in the field of disposable duodenoscopes; notably, on December 13, 2019, Boston Scientific's EXALT Model D received FDA clearance for use in ERCP, rendering it the first fully disposable duodenoscope on the market. Other notable events contributing to innovation to reduce risks in this space include acquisitions, partnerships, and the approval of disposable duodenoscope tips.

Recent Events in the Duodenoscope Market

Date Event
December 2019 Boston Scientific gains FDA 510(k) clearance for the EXALT Model D single-use duodenoscope
November 2019 Pentax launches the DEC Duodenoscope ED340-i10T with disposable components in the US
August 2019 Stryker acquires TSO3, a manufacturer of sterilization devices used in hospital settings for colonoscopes, gastroscopes, and duodenoscopes
August 2019 FDA issues a recommendation for hospitals and facilities to transition away from reusable duodenoscopes and toward disposable duodenoscopes
May 2019 Ambu and Cook Medical announce a partnership to introduce the former's single-use duodenoscope into the US market via the latter's distribution channels
March 2019 FUJIFILM receives FDA clearance for its ED-580XT disposable endcap duodenoscope
September 2017 PENTAX Medical receives a CE mark for its DEC Duodenoscope ED340-i10T with disposable components

 

Going forward, other market developments, including the entrance of new competitors, are expected. For example, Ambu, which is headquartered in Denmark and has already introduced its single-use aScope product for ENT and bronchoscopy applications, has a single-use duodenoscope that is pending FDA approval; Ambu announced in 2019 that it had partnered with Cook Medical to distribute the single-use duodenoscope globally once it is approved.

Moreover, having already received FDA approval for its fully disposable duodenoscope, Boston Scientific is now aiming for global commercialization; the company has planned a multicenter global clinical trial for the EXALT model D that is expected to start by early 2020.

In addition to eliminating the potential for disease transmission, disposable duodenoscopes could increase accessibility to the ERCP procedures that these endoscopes are designed to perform. This is because the cost of acquiring them is expected to be a fraction of the current US average selling price of approximately $30,000 for reusable duodenoscopes.

“The release of the first disposable duodenoscope marks a new era in this market that has the potential to transform a part of healthcare. Patients will be safer and potentially more patients will gain access to ERCP than in the past when very expensive capital equipment was the only route to endoscopy. It will be interesting to learn more about how providers intend to integrate disposable duodenoscopes into their practice as specialists gain greater familiarity and experience with this new option.”

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