REAPING THE REWARDS OF SINGLE-USEEFFICIENCY AND STERILITY
The Ambu® aScope™ Colon constitutes a new sterile tool for GI professionals during interventional and diagnostic procedures. Due to the guaranteed sterility of the single-usecolonoscope, the risk of cross-contaminationis removed, and the scope can hereby serve as a unique medical device for the treatment of patients who suffer from serious infections or are immunocompromised.
Moreover, Ambu's colonoscope presents the opportunity for colonoscopists and nursing staffs in the U.S. to reap the rewards of single-usein terms of availability, efficiency and workflow optimisation. GI professionals using single-useendoscopes are not limited by the number of available scopes at hand - nor are they subjects to the rigid reprocessing requirements that come with reusable endoscopes. Instead, they are offered the flexibility of single-useand, with that, the opportunity to improve their planning and management of schedules, in turn, potentially saving patients from the bother of cancellations and rescheduling.
" In line with our strategic decision to apply a niche-basedapproach on our GI journey, we are dedicated to engaging with selected U.S. customers to test the performance of our new colonoscope solution. Our entry into the gastroenterology market is one of learning and focus, and as we gradually expand our offering, we are looking forward to bringing the power of single-useefficiency and sterility to a growing number of healthcare professionals and patients.
BRITT MEELBY JENSEN
Chief Executive Officer, Ambu
Chief of Gastroenterology, Interventional Endoscopist, New York, NY, USA
ADAM GOODMAN, MD
The Ambu aScope Colon is a pioneer step, making the single-useconcept available for colonoscopy. We are looking forward to evaluating the performance and potential patient benefits of this technology.
The colonoscopy market is the biggest endoscopy segment, not only in GI, but across all endoscopy segments, representing approximately 40 million procedures annually. Ambu's colonoscope solution is designed to meet the needs pertaining to 1.5 million of these procedures, and with the FDA clearance, Ambu will apply an initial market test approach in
a few dedicated U.S. centers to evaluate clinical performance, in close collaboration with physicians.
"
PRESS
RELEASE
20 September 2023
AMBU ANNOUNCES FDA CLEARANCE OF FIRST- GENERATION SINGLE-USECOLONOSCOPE
With the new colonoscopy solution, Ambu complements its gastroenterology offering by bringing single-useefficiency to colonoscopists and patients for interventional and diagnostic procedures.
Today, Ambu announces 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) of its single-usecolonoscope solution, the Ambu® aScope™ Colon and the endoscopy system, the Ambu® aBox™ 2.
With a 3.7 mm working channel and just 11.5 mm outer diameter, the new colonoscope complements Ambu's gastroenterology (GI) portfolio, consisting of the Ambu® aScope™ Gastro and the Ambu® aScope™ Gastro Large - all of which are supported by the ecosystem software platform featured in the Ambu® aBox™ 2.
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