Sam Brusco, Associate Editor04.22.24
Ambu has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Ambu aScope Duodeno 2 and aBox 2, its new duodenoscopy solution, for endoscopic retrograde cholangiopancreatography (ERCP) procedures.
The new-generation aScope Duodeno 2, according to Ambu, aims to relieve the burden of complex, time-consuming reprocessing. It’s 100% sterile so doctors and hospitals can follow the safety recommendations from the FDA issued in 2019 and 2022 that advise facilities to transition to partially or completely single-use duodenoscopes.
The scope’s new ergonomic handle also serves the purpose of reducing endoscopist strain, according to the company. Ambu said it plans to include bioplastic materials in the handle over time—specifically, materials derived from a mix of fossil-based and second-generation bio-based feedstock. This includes recycled food waste for a raw material with a lower carbon footprint.
To achieve this design, Ambu worked with experience gastroenterology professionals and ERCP specialists to rethink its duodenoscopy solution.
“Based on their feedback, we have developed a solution to meet the distinct procedural needs in ERCP,” commented Ambu CEO Britt Meelby Jansen. “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.”
The company will launch an extended, controlled market released to evaluate clinical performance, and the solution will become available from 2024/25.
In February, Ambu’s aScope 5 Broncho HD single-use bronchoscope was granted a transitional pass-through (TPT) payment from the Centers for Medicare & Medicaid Services (CMS).
The new-generation aScope Duodeno 2, according to Ambu, aims to relieve the burden of complex, time-consuming reprocessing. It’s 100% sterile so doctors and hospitals can follow the safety recommendations from the FDA issued in 2019 and 2022 that advise facilities to transition to partially or completely single-use duodenoscopes.
The scope’s new ergonomic handle also serves the purpose of reducing endoscopist strain, according to the company. Ambu said it plans to include bioplastic materials in the handle over time—specifically, materials derived from a mix of fossil-based and second-generation bio-based feedstock. This includes recycled food waste for a raw material with a lower carbon footprint.
To achieve this design, Ambu worked with experience gastroenterology professionals and ERCP specialists to rethink its duodenoscopy solution.
“Based on their feedback, we have developed a solution to meet the distinct procedural needs in ERCP,” commented Ambu CEO Britt Meelby Jansen. “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.”
The company will launch an extended, controlled market released to evaluate clinical performance, and the solution will become available from 2024/25.
In February, Ambu’s aScope 5 Broncho HD single-use bronchoscope was granted a transitional pass-through (TPT) payment from the Centers for Medicare & Medicaid Services (CMS).