Danish medical device company Ambu has received the US Food and Drug Administration (FDA) 510(k) approval for its aScope Duodeno 2 solution, compatible with its aBox 2 system.

The new-generation diagnostic solution is indicated for the endoscopic retrograde cholangiopancreatography (ERCP) procedures.

The aScope Duodeno 2 is a 100% sterile solution that enables physicians and hospital systems to provide safe treatment as recommended by the US FDA in 2019 and 2022.

Ambu said that its aScope Duodeno 2 solution aims to address the high demand for ERCP performance and reduce complex reprocessing in current practice.

The handle of its aScope Duodeno 2 solution is designed with improved ergonomics to alleviate strain on endoscopists during long and complex ERCP procedures.

In addition, the medical device maker intends to include bioplastic materials, derived from fossil-based and bio-based feedstock, into the handle of the new solution.

Ambu CEO Britt Meelby Jensen said: “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 dedicated to continuing 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.”

Ambu said that its new generation duodenoscopy solution has been developed by working closely with experienced gastroenterology professionals and ERCP specialists.

The company had a clear focus on enhancing critical performance factors and enabling integration with the aBox 2 endoscopy system.

The new aScope Duodeno 2 solution will be commercialised in this financial year.

The medical device maker intends to conduct an extended controlled market release with key hospitals to evaluate the clinical performance in a real-life setting.

Florida Gastroenterologic Society interventional gastroenterology president Abhitabh Patil said: “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.”