Boston Scientific wins FDA clearance for single-use endoscope
Photo | Grant Welker
Boston Scientific headquarters in Marlborough
Boston Scientific has won regulatory clearance for what it says is the first disposable duodenoscope, a device inserted through the mouth so doctors can look into the small intestine.
A single-use duodenoscope eliminates the typical need for reprocessing and repairs following a procedure, the Marlborough firm said Friday in announcing the approval.
The EXALT, as the device is called, was given the U.S. Food and Drug Administration's breakthrough device designation, an expedited process for products providing for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography, or ERCP, procedures each year in the United States, according to the FDA. The procedure is used to diagnose and treat problems in the pancreas and bile ducts.
Both the FDA and Boston Scientific have noted cases of contamination with reusable duodenoscopes, a problem Boston Scientific said will be addressed through the use of disposable components.
Boston Scientific said it plans to begin a limited market release of EXALT in the first quarter.
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