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 re-usable duodenoscopes with endcaps that were more difficult to clean and led to “superbug” infections in 1 in 20 cases. 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.
Boston Scientific’s chief medical officer Dr. Brian Dunkin 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.