Boston Scientific Corporation has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is an FDA-cleared single-use (disposable) duodenoscope that was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.
The device has been developed 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.
Every year, more than 1.5 million ERCPs are performed worldwide using duodenoscopes to diagnose and treat various pancreatic and biliary conditions.
Reusable duodenoscopes are put through a rigorous disinfection process between uses in different patients and the vast majority of procedures with these devices are carried out safely and effectively; however, there have been a small number of cases in which infections have been transmitted between patients via contaminated devices, despite adherence to established protocols. As a result, the FDA has been working with duodenoscope manufacturers, medical societies, physicians and other stakeholders to address this concern.
The FDA recently issued a recommendation that healthcare providers transition to duodenoscopes with disposable components or fully disposable devices, when they are available, and held an advisory committee meeting to discuss this process and other issues related to reducing infection transmission by reusable duodenoscopes.
The FDA Breakthrough Devices Program is intended to help patients receive timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
Boston Scientific voluntarily conducted a consecutive case series of the EXALT Model D Duodenoscope and found that expert endoscopists were able to complete ERCPs across a wide range of complexity using the single-use duodenoscope.
The company plans to commence a limited market release of the device in the U.S. during the first quarter of 2020.