duodenoscope Archives - Medical Design Sourcing

5 challenges Boston Scientific overcame to make single-use scopes work

FDA wanted single-use scopes to reduce potentially deadly superbug infections. Here’s how Boston Scientific made it happen. The Exalt Model D single-use duodenoscope [Image courtesy of Boston Scientific]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.

FDA clears Ambu single-use duodenoscope

Ambu’s aScope Duodeno single-use duodenoscope [Image courtesy of Ambu]

Ambu announced today that FDA has cleared its aScope Duodeno — a sterile, single-use duodenoscope meant to avoid the deadly superbug outbreaks that cropped up around reusable versions of the scopes.

Other companies — including Boston Scientific (NYSE:BSX), Hoya’s (TYO:7741) Pentax subsidiary, and Olympus (TYO:7733) — have been releasing either fully disposable duodenoscopes or duodenoscopes with disporable endcaps or disposable elevators.

Duodenoscopes provide a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions — with an estimated 600,000 procedures conducted annually in the United States.

FDA has been pushing duodenoscope makers to change designs, and CMS has been working to speed up Medicare beneficiar…

CMS moves to boost access to Boston Sci’s single-use duodenoscope

The Exalt Model D single-use duodenoscope from Boston Scientific [Image courtesy of Boston Sci]

Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope.

The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide people with access to innovative medical technologies while needed cost data is collected.

Single-use duodenoscopes matter. The devices provide a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. But reprocessing the scopes has proved especially tricky — with the scopes in the past conne…