Substantial clinical data proves feasibility, safety and performance
EXALT™ Model D Single-Use Duodenoscope has seven peer-reviewed, published studies – including six trials where patients were consecutively enrolled – to allow for a wide range of challenging ERCPs. Explore the data and get physician perspectives about high-risk patient selection.
91.3%
procedural success rate with a single-use duodenoscope in an international, multi-site evaluation over 550+ procedures1
7
peer-reviewed, published studies1-7
1,100
patients across all ASGE complexity grades* 1-7
Clinically proven results for EXALT Model D
In a large, international, multi-site study academic endoscopists used the first marketed single-use duodenoscope to successfully complete 503 scheduled ERCP cases with a range of complexity in a diverse patient population. Consistent with past studies, the device showed good performance* and an SAE rate comparable to published estimates for reusable duodenoscopes.1
*Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 1) [best].
60-patient consecutive series in U.S. resulting in 58/60 successful ERCP procedures with a single-use duodenoscope alone.2
Randomized head-to-head trial against market-leading reusable duodenoscope demonstrating overall safety profile and similar technical performance.3
60-patient consecutive series in France resulting in 57/60 successful ERCP procedures with a single-use duodenoscope alone.4
200-patient consecutive series suggesting similar performance between endoscopists of varying experience levels.5
201-patient head-to-head comparison with a competing duodenoscope showing a 54.5% lower crossover rate (10% vs. 22%).6
52-patient consecutive series showing 95.3% of ratings were neutral in comparison to a reusable duodenoscope (141/148).7
Substantial clinical data proves feasibility, safety and performance
EXALT™ Model D Single-Use Duodenoscope has seven peer-reviewed, published studies – including six trials where patients were consecutively enrolled – to allow for a wide range of challenging ERCPs. Explore the data and get physician perspectives about high-risk patient selection.
91.3%
procedural success rate with a single-use duodenoscope in an international, multi-site evaluation over 550+ procedures1
7
peer-reviewed, published studies1-7
1,100
patients across all ASGE complexity grades* 1-7
Clinically proven results for EXALT Model D
In a large, international, multi-site study academic endoscopists used the first marketed single-use duodenoscope to successfully complete 503 scheduled ERCP cases with a range of complexity in a diverse patient population. Consistent with past studies, the device showed good performance* and an SAE rate comparable to published estimates for reusable duodenoscopes.1
*Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 1) [best].
60-patient consecutive series in U.S. resulting in 58/60 successful ERCP procedures with a single-use duodenoscope alone.2
Randomized head-to-head trial against market-leading reusable duodenoscope demonstrating overall safety profile and similar technical performance.3
60-patient consecutive series in France resulting in 57/60 successful ERCP procedures with a single-use duodenoscope alone.4
200-patient consecutive series suggesting similar performance between endoscopists of varying experience levels.5
201-patient head-to-head comparison with a competing duodenoscope showing a 54.5% lower crossover rate (10% vs. 22%).6
52-patient consecutive series showing 95.3% of ratings were neutral in comparison to a reusable duodenoscope (141/148).7
