EXALTTM Model D Single-Use Duodenoscope
Changing the standard of care for ERCP procedures with the world’s first and only single-use, sterile duodenoscope designed to be lightweight, consistent and high-performing.
"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.” — Dr. Raman Muthusamy, Medical Director of Endoscopy, Professor of Clinical Medicine, David Geffen School of Medicine at UCLA.
Human use clinical trial patients
|In a consecutive case series of the EXALT Model D Duodenoscope, 60 ERCPs, of all 4 ASGE complexity levels, were completed across six sites in the United States for indications including pancreaticobiliary stone clearance, stent placement, exchange and/or removal and balloon dilation.1|
ERCP procedures completed with EXALT alone
|All ERCP procedures were successfully performed, of which 96.7% were completed with the single-use duodenoscope alone and 3.3% with crossover to a reusable duodenoscope.|
Median overall satisfaction
|The median overall satisfaction with the
single-use duodenoscope by phisicians was rated a 9 out of 10
1Muthusamy VR1, Bruno MJ, Kozarek RA3, Petersen BT4, Pleskow DK5, Sejpal DV6, Slivka A7, Peetermans JA8, Rousseau MJ8, Tirrell GP8, Ross AS3. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2019 Nov 6. pii: S1542-3565(19)31261-3. doi: 10.1016/j.cgh.2019.10.052. [Epub ahead of print]
Duodenoscope Safety Communications
There have been more safety communications on duodenoscopes than any other medical device since 2013. The environment, equipment and guidelines that inform cleaning procedures are constantly changing putting duodenoscope reprocessing into a state of transition. Recently, the FDA recommended healthcare providers transition to duodenoscopes with disposable components or fully disposable devices.
EXALT Model D Single-Use Duodenoscope is a fully disposable option.
FDA Grants Breakthrough Device Designation
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CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.All photographs taken by Boston Scientific.