Boston Scientific Gets Breakthrough Approval and Pass-Through Payment for Pioneering Single-Use Duodenoscope

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Boston Scientific’s Breakthrough-designated EXALT Model D Single-Use Duodenoscope, the first single-use scope of its kind, recently received FDA clearance and is among the first devices to receive transitional pass-through payment status from CMS under a new pathway announced earlier this year.

In the world of medical devices, duodenoscopes have had one of the most concerning safety records. The traditionally reusable scopes, used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose or treat bile duct, liver, gall bladder, and pancreas conditions, have been linked to persistent contamination issues, outbreaks of multi-drug-resistant bacterial infections, and multiple patient deaths. Since 2013, there have been more FDA Safety Communications on duodenoscopes than any other medical device. Adding to this, equipment and cleaning procedure guidelines for these complex devices are constantly changing, putting reprocessing procedures into a confusing state of transition. Importantly also, the COVID-19 pandemic has heightened concerns over infection control and cross-contamination. Approximately 700,000 duodenoscope procedures are performed in the US each year, and 1.5 million worldwide.

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