Performance
In Clinical Use
Healthcare professionals / Gastroenterology / EXALTTM Model D Single-Use Duodenoscope / Clinical / Clinical Trial Data
Clinically Verified1
“We decided to do a trial, even though it wasn’t mandated by the FDA which is fairly unprecedented. We wanted to reassure physicians that EXALT Model D was not going to compromise the quality of the procedure. We had expert clinicians who know the nuances of the procedure confirm that EXALT Model D performed as expected. The feedback we received from clinicians as part of this trial was invaluable.”
Dr. Brian Dunkin, Chief Medical Officer, Boston Scientific Endoscopy
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60Human 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 |
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96.7%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. |
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9/10Median overall satisfaction |
The median overall satisfaction with the single-use duodenoscope by phisicians was rated a 9 out of 10 |
1Muthusamy VR, Bruno MJ, Kozarek RA, Petersen BT, Pleskow DK, Sejpal DV, Slivka A, Peetermans JA, Rousseau MJ, Tirrell GP, Ross AS. 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]
Read how a rural hospital brought ERCP to their practice with EXALT Model D.
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