CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D

Boston Scientific Exalt

Boston Scientific Corporation has gained the CE Mark and initiated a limited market release of the EXALT™ Model D Single-Use (disposable) Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. 

Background

More than 500,000 ERCPs are performed in Europe each year, using duodenoscopes to facilitate diagnosis and treatment of various pancreatic and biliary conditions such as stones or blockages within the pancreatobiliary system.

Duodenoscope reprocessing, however rigorous, has in the past lead to reports, albeit rare, of nosocomial infections linked to endoscopic procedures.

Boston Scientific’s EXALT Model D Duodenoscope is the first and only CE Marked and FDA cleared single-use disposable duodenoscope on the market. It was also granted Breakthrough Device Designation from the FDA. In Europe, the EXALT Model D Duodenoscope will be available to hospitals as an alternative to reusable duodenoscopes, eliminating the need for duodenoscope reprocessing and repairs and allowing physicians to use a new, sterile device for every procedure.  

The EXALT Model D Duodenoscope builds on the familiar design of standard reusable duodenoscopes so that physicians experience a minimal learning curve when adopting this technology.  

Boston Scientific says it now plans to commence a limited market release of EXALT Model D in Europe during the first quarter of 2020, beginning in Germany, France, Italy, UK and Sweden.

Clinician comments

“With the EXALT Model D Duodenoscope, I can perform the same high-quality ERCP procedure with the added benefit of using a brand-new sterile device for each patient, thereby avoiding any cross-patient contamination and infection risk,” said Professor Marco Bruno, Professor of Gastroenterology & Hepatology, Head of the Department of Gastroenterology & Hepatology, Erasmus Medical Center, University Medical Center Rotterdam, The Netherlands. 

“I am excited by the launch of this device, which I see as a significant advancement in the evolution of endoscopy.” 

Company comments

“Following on from the recent FDA clearance of the EXALT Model D Duodenoscope, I am delighted that we have completed CE Mark in Europe and that our physicians and hospitals will have access to the world’s first single use duodenoscope,” said Darragh Tolan, vice president, Endoscopy, Boston Scientific.

“Patients and hospitals depend on us to protect life-saving ERCP procedures and avoid potential infections and we pride ourselves on offering them not just the highest quality devices, but our partnership and solutions. The EXALT Model D Duodenoscope is a prime example of our work not just in advancing the care of pancreaticobiliary diseases, but our commitment to being at the forefront of innovation and working together to improve patient outcomes.” 

Source: Boston Scientific Corporation

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