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Boston Scientific Lands NTAP Status For Single-Use Scope

Executive Summary

US Medicare’s designation of Boston Scientific’s single-use duodenoscope aims to reduce infections from a popular procedure to treat pancreatic and biliary conditions.

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US Medicare Extends Add-On Payments For 13 Technologies

Citing the pandemic, the US Centers for Medicare & Medicaid Services (CMS) discounted 2020 data in reviewing renewals for New Technology Add-On Payment (NTAP) status and granted extensions through 30 September to 13 NTAP products.

‘Right Product, Right Time:’ FDA Clears Boston Scientific's Single-Use Duodenoscope

Amid concerns of infections from duodenoscopes that are not sufficiently re-sterilized, the US FDA has cleared Boston Scientific’s Exalt-D as a the first single-use duodenoscope. Investors expect the device will likely take a significant chunk of the market, especially considering the next competitor is at least a year away.

Continued Risks Of Duodenoscopes Leads FDA To Recommend Disposable Cap Devices

After a study earlier this year found that fixed endcap duodenoscopes continued to pose a significant risk of infecting patients after being washed, the US agency is now urging providers to switch to newer-designed scopes that reduce or eliminate the risk from reprocessing, such as duodenoscopes that have interchangeable caps. The directive from the FDA is good news for Boston Scientific, which makes a disposable duodenoscope that is close to being approved by the agency.

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