Proven with
peer-reviewed,
published clinical data
Substantial clinical data has been published for the EXALTTM Model D Single-Use Duodenoscope
EXALT Model D peer-reviewed, published data, includes one trial where patients were consecutively enrolled. Explore the data and get physician perspectives about high-risk patient selection.
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.1
 |
100% |
100% of ERCP procedures were successfully performed
| |
96.7% |
96.7% of ERCP procedures were completed with EXALT Model D alone and 3.3% with crossover to a reusable duodenoscope
| |
9/10 |
The median overall physician satisfaction for the EXALT Model D Single-Use duodenoscope scope by physicians was 9 out of 10
“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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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.
Bang JY, et al. | Gut 2020
Equivalent performance of single-use and reusable duodenoscopes in a randomised trial2
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 study3
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.
Reduce Infection risk for the most vulnerable
Understand the risk factors that may impact a patient’s risk for infection during ERCP.
EXALT™ Model D
Single-Use Duodenoscope
delivers robust stability, maneuverability
and control in ERCP procedures.
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