The Exalt Model D Single-Use Duodenoscope is designed for use in endoscopic retrograde cholangiopancreatography procedures. It is the first single-use duodenoscope on the U.S. market and was granted Breakthrough Device Designation. The FDA cleared the device late last year.
“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,” VP of endoscopy Darragh Tolan said in a news release. “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.”
Duodenoscopes have traditionally been intended for use on multiple patients with cleaning and disinfecting happening between each use. However, the devices are complex and its many small moving parts can trap contaminated tissue or fluids. The devices have sparked controversy in recent years because they can transmit infection-causing bacteria between patients, according to the FDA.
“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,” Marco Bruno, head of the department of gastroenterology and hematology at Erasmus Medical Center at the University Medical Center in Rotterdam, The Netherlands, said. “I am excited by the launch of this device, which I see as a significant advancement in the evolution of endoscopy.”
Boston Scientific plans to start a limited market release of the disposable duodenoscope in Europe during the first quarter of 2020, beginning in Germany, France, Italy, U.K. and Sweden.