Boston Scientific Lands NTAP Status For Single-Use Scope
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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The US FDA says medical facilities should transition to duodenoscopes with disposable endcaps or fully disposable ones to limit device contamination and patient-to-patient infection.
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.
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.