AMBU OBTAINS FDA CLEARANCE FOR NEW GENERATION DUODENOSCOPY SOLUTION

Today, Ambu announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of its new generation duodenoscopy solution, Ambu^® aScope™ Duodeno 2 and Ambu^® aBox™ 2, for use in ERCP¹ procedures.

In the development of the new generation solution, Ambu has worked closely with a range of experienced gastroenterology professionals and ERCP specialists to rethink its duodenoscopy solution, with a clear focus on enhancing critical performance factors and enabling integration with the aBox™ 2 endoscopy system.

"I am impressed with the improvements in the new aScope Duodeno 2, and I believe that it holds potential for ERCP in the future. Ambu has clearly taken the customer feedback into the development of this new duodenoscope. I highly valued the collaboration throughout the development phase, and I am looking forward to continuing to engage with Ambu on future innovations."

ABHITABH PATIL, M.D.²
Interventional Gastroenterology
President of Florida Gastroenterologic Society
St. Petersburg, FL
 

PROVIDING FLEXIBILITY AND STERILITY WITH PATIENT-READY DUODENOSCOPES

The new generation aScope™ Duodeno 2 solution is designed to meet the high-performance expectations in ERCP and furthermore relieve the burden of complex and time-consuming reprocessing conducted today. As aScope™ Duodeno 2 is 100% sterile, the solution enables physicians and hospital systems to adhere to the safety recommendations issued by the FDA³ in 2019 and 2022, urging U.S. hospitals and endoscopy facilities to transition to duodenoscopes that are partially or completely single-use.

Furthermore, given the often long and physically demanding nature of ERCP procedures, the handle of Ambu’s new generation aScope Duodeno 2 solution aims to alleviate strain on endoscopists through improved ergonomics. In addition, Ambu is planning to include bioplastic materials in the handle of the new generation solution over time – materials that are derived from a mix of fossil-based and second-generation bio-based feedstock, e.g., recycled food waste, ensuring a raw material with a lower carbon footprint.

"Our new generation duodenoscope solution is a result of a close partnership with gastroentero­logists. Based on their feedback, we have developed a solution to meet the distinct procedural needs in ERCP. We are dedicatedcontinuing Ambu’s focused journey within GI, anchored in profound customer understanding as a pivotal driver for unlocking long-term potential – for gastroenterologists, patients and Ambu."

BRITT MEELBY JENSEN
Chief Executive Officer, Ambu

Ambu will conduct an extended controlled market release with key hospitals to evaluate the clinical perfor­mance in a real-life setting. The solution will be available in the market from 2024/25, and the FDA clearance will therefore not change the financial guidance for 2023/24.

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1. ERCP stands for endoscopic retrograde cholangiopancreatography and serves both diagnostic and therapeutic purposes for various conditions affecting the bile ducts and pancreas, including gallstones, strictures and tumours.
2. Dr. Patil a paid consultant of Ambu A/S. He has not been compensated for his quote in this press release.
3. Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Not all Ambu products are available for commercial sale in all countries.