Ambu has obtained 510(k) regulatory clearance from the US Food and Drug Administration (FDA) for its new-generation duodenoscopy solution, the aScope Duodeno 2 and aBox 2, which is designed for endoscopic retrograde cholangiopancreatography (ERCP) procedures.
The aScope Duodeno 2 solution is aimed at meeting the high-performance expectations in ERCP and addressing the complex reprocessing challenges currently faced by healthcare providers.
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The aScope Duodeno 2 and aBox 2 are engineered to meet the requirements of gastroenterologists performing ERCP, a complex and often physically demanding procedure.
Ambu’s collaboration with experienced gastroenterology professionals and ERCP specialists has led to enhancements in critical performance factors and seamless integration with the aBox 2 endoscopy system.
The aScope Duodeno 2 is a fully sterile, single-use solution, aligning with FDA safety recommendations of 2019 and 2022 to transition towards partially or completely single-use duodenoscopes.
The improved ergonomics of aScope Duodeno 2 also aim to reduce strain on endoscopists during lengthy procedures.
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By GlobalDataAmbu is planning to incorporate bioplastic materials into the handle of the new generation aScope Duodeno 2 solution over time.
An extended controlled market release with key hospitals is planned to evaluate the clinical performance of the aScope Duodeno 2 in real-life settings.
The solution is expected to be available in the market from 2024/2025, and the recent FDA clearance will not impact Ambu’s financial guidance for 2023/2024.
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.”
Earlier this month, the company also secured FDA 510(k) clearance for its therapeutic gastroscope solution, the aScope Gastro Large and aBox 2.
With a 4.2mm working channel and powerful suction performance, aScope Gastro Large is designed to meet acute therapeutic procedure requirements in the ICU, including bleed management and food impaction.
