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 beneficiaries’ access to single-use endoscopes.
“At Ambu, we are determined to advance patient safety through innovative design of single-use devices, and we are excited to improve safety for the 2 million patients each year who require an ERCP (endoscopic retrograde cholangio-pancreatography) procedure,” said Juan Jose Gonzalez, CEO of Ambu A/S (Copenhagen, Denmark).
“It’s no longer necessary to balance the necessity of the procedure against the risk of infection from a reusable endoscope. Now, both doctor and patient can focus on diagnosis and treatment by using a sterile, single-use duodenoscope,” Gonzalez said in a news release.
Ambu will initiate a 500-patient post-market study at multiple U.S. centers and will release a sub-set of the study during Q1 of its 2020/21 financial year.
Ambu plans to introduce 15 new devices across all major areas of endoscopy over the next three years. The company in May announced the launch of its Ambu aView 2 Advance display unit for use with endoscopes in Europe and the U.S.