On Dec. 13, 2019, the U.S. Food and Drug Administration (FDA) approved Boston Scientific's Exalt Model D single-use duodenoscope. The Exalt Model D authorization marks the first time the FDA has approved a single-use duodenoscope for physician use.
The disposable duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to assist in diagnosis and treatment for an assortment of upper gastrointestinal tract disorders, such as bile duct disorders.
The Exalt Model D authorization will give physicians a sterile alternative to the current reusable duodenoscopes which require repairs and sterilization between procedures. While the Pentax Medical Video ED34-i10T2 was approved last month with disposable parts, the Exalt Model D is still the only device on the market that is completely disposable.
According to Boston Scientific, the Exalt Model D is highly similar in design to current reusable duodenoscopes, so doctors should experience a mild learning curve. Boston Scientific also stated that in numerous test cases, the Exalt Model D, wielded by endoscopists, performed endoscopic retrograde cholangiopancreatography procedures of varying complexities with great success.
Boston Scientific will begin a limited release of the Exalt Model D in the United States in the first quarter of 2020. Endoscopists that spoke to Medscape expressed overall positive sentiments about the Exalt Model D authorization, commenting on the importance of sterile tools when completing tasks in such a sensitive region and how the FDA’s approval marked an overall forward movement in increasing patient safety and physician confidence in procedures.