Proven success with
peer-reviewed,
published clinical data
EXALTTM Model D Single-Use Duodenoscope / Clinical Data
Substantial clinical data proves feasibility, safety and performance
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91.3%procedural success rate with a single-use duodenoscope in an international, multi-site evaluation over 550+ procedures1 |
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7peer-reviewed, published
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1,100patients across all ASGE complexity grades* 1-7 |
Clinically proven results for EXALT Model D
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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]. |
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60-patient consecutive series in U.S. resulting in 58/60 successful ERCP procedures with a single-use duodenoscope alone.2 |
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Randomized head-to-head trial against market-leading reusable duodenoscope demonstrating overall safety profile and similar technical performance.3 |
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60-patient consecutive series in France resulting in 57/60 successful ERCP procedures with a single-use duodenoscope alone.4 |
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200-patient consecutive series suggesting similar performance between endoscopists of varying experience levels.5 |
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201-patient head-to-head comparison with a competing duodenoscope showing a 54.5% lower crossover rate (10% vs. 22%).6 |
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52-patient consecutive series showing 95.3% of ratings were neutral in comparison to a reusable duodenoscope (141/148).7 |
Muthusamy VR, et al. | Clin Gastroenterol Hepatol. 2020
Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography
In a consecutive case series testing the feasibility, preliminary safety and performance of a single-use duodenoscope, 60 ERCPs of all four 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.2
| In the study: | ||
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100% |
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| of ERCP procedures were successfully performed | ||
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96.7% |
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| of ERCP procedures were completed with EXALT Model D alone (3.3% with crossover to a reusable duodenoscope) | ||
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9/10 |
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| median overall physician satisfaction for the EXALT Model D | ||
EXALT Model D clinical trial evaluation
Dr. Kenneth Binmoeller discusses the clinical evaluation of the EXALT Model D Single-Use Duodenoscope and how it helps support the readiness of the device for clinical use.
“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
Bang JY, et al. | Gut 2020
Equivalent performance of single-use and reusable duodenoscopes in a randomised trial3
This randomised trial of 98 patients compared the performance of the EXALT Model D Single-Use Duodenoscope with reusable duodenoscopes in patients undergoing ERCP.
- Overall technical performance and safety profile were similar between the EXALT Model D Single-Use Duodenoscope and reusable duodenoscopes.
- 46 out of 48 patients were successfully cannulated using the EXALT Model D Single-Use Duodenoscope.
- Median number of attempts to achieve successful cannulation was significantly lower for the EXALT Model D Single-Use Duodenoscope as compared to reusable duodenoscopes.
Napolean N, et al. | Digestive Endoscopy 2021
Evaluation of the performance of a single-use duodenoscope: Prospective multi-center study4
In a consecutive case series evaluating the feasibility, safety and performance of a single-use duodenoscope, 60 ERCPs of all four ASGE complexity levels were completed across six sites in France for indications including pancreaticobiliary stone clearance, stent placement and/or removal and balloon dilation.
- 95% of ERCP procedures were completed with EXALT Model D alone. Three procedures required cross-over to a reusable duodenoscope and were also unsuccessful.
- The median overall physician satisfaction for the EXALT Model D Single-Use duodenoscope scope by physicians was 9 out of 10.
- Demonstrates EXALT Model D’s pre-market clinical trial results can be independently reproduced.
Physician perspectives
Whitepaper
The ERCP patient: Risk factors for infection
Although the risk for post-ERCP infection is rare, some patients are more vulnerable to infection than others. Read this in-depth whitepaper to better understand the factors that may impact a patient’s risk for infection during ERCP.
Read the whitepaper
Physicians discuss high risk patient selection
Watch the videos below to hear two physicians discuss patient selection for EXALT Model D.
Dr. Kenneth Binmoeller
How do we start with patient selection?
Dr. Kenneth Binmoeller discusses how to start and the path forward for using disposable scopes.
Professor Alessandro Repici
Do we require a patient selection protocol?
Professor Alessandro Repici talks about which patients you may want to consider for a single-use scope if not adopting for all patients.
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