FDA wanted single-use scopes to reduce potentially deadly superbug infections. Here’s how Boston Scientific made it happen.Boston Scientific’s Exalt Model D Single-Use Duodenoscope received FDA clearance in December 2019. It was the first device of its kind to hit the medical market. Just five months earlier, the FDA urged device manufacturers to move away from fully reusable duodenoscopes to scopes with disposable endcaps — or even fully disposable duodenoscopes. A culturing study had found an up to 5.4% contamination rate for high-concern bugs like E. coli and Pseudomonas aeruginosa.
As it so happened, Boston Scientific was already working on a single-use scope.
Now on the market, Exalt is making its way into physician’s offices, but it was a complicated journey.
Dr. Brian Dunkin, chief medical officer of Boston Scientific’s Endoscopy division, recently told our sister site Medical Design & Outsourcing that the company overcame five challenges to make Exalt a reality. Go to MDO to read more.