Ambu has announced 510(k) regulatory clearance of the Ambu aScope Gastro and Ambu aBox 2 in the United States. aScope Gastro is Ambu’s first sterile single-use gastroscope and includes new advanced imaging and design features in a combined solution with next-generation display and processor technology. With HD capabilities, the aBox 2 will set a new benchmark in terms of image quality and will be at the centre of Ambu’s endoscopy ecosystem.
With the launch of aScope Gastro, Ambu enters the gastroscopy segment, where 20 million procedures take place annually with reusable endoscope systems.
The advanced technology, portability, and cost-effectiveness of Ambu’s solution address the current limitations of reusable endoscopes, and it will be an attractive choice for customers looking to perform gastroscopies across a wide range of care settings (including endoscopy unit, OR, ICU, ER, ASC). Furthermore, the aScope Gastro will support healthcare systems in their efforts to reduce waiting lists and overcome staff shortages, which have been accentuated since the start of the COVID-19 pandemic. Finally, the sterile offering provides a solution to the growing cross-contamination risks, especially for vulnerable patients.
“The Ambu system comes at a time where we’re dealing with waiting lists and staff shortages, and where the ease of setup and elimination of reprocessing, are major advantages. Also, the combination of a sterile single-use gastroscope and a compact display unit opens up the opportunity to expand endoscopy to alternative settings, such as Intensive Care Units,” says Prof. Pradeep Bhandari[1], Queen Alexandra Hospital, Portsmouth, UK.
“In the OR setting, having a single-use scope that is immediately available with a small footprint, which requires much less up-front capital outlay than a reusable setup, will be valuable to many hospitals across the country,” says Reginald Bell[1], M.D., F.A.C.S, Institute of Esophageal and Reflux Surgery, Lone Tree, Colorado, USA.
With this FDA clearance, Ambu will proceed with commercialisation of the aScope Gastro and aBox 2 in the United States.
Together with the launch of the aScope™ Duodeno 1.5, the aScope Gastro represents the next step in Ambu’s expansion into the GI segment. They will be followed by the next generation single-use duodenoscope (aScope Duodeno 2.0), a colonoscope and a cholangioscope, giving Ambu the most comprehensive single-use portfolio in GI.
“Gastroscopy is not only one of the largest segments in endoscopy, but also has all the conditions to benefit from single-use endoscopy. There is a clear need for more convenience, flexibility, and infection control, which are all addressed with the introduction of our aScope Gastro,” says Juan Jose Gonzalez, CEO of Ambu. “The technology in our aScope Gastro and aBox 2 will set a new benchmark in terms of image quality and functionality and will power all of our next-generation launches. Our expansion within GI will extend Ambu’s position as the world’s most innovative single-use endoscopy player.”
[1] Prof. Bhandari and Dr. Bell are paid consultants of Ambu A/S. They have not been compensated for their quotes within this press release.
