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EXALT Model D Single-Use Duodenoscope Generation 4 clinical data.

Success shown in published clinical studies

Substantial clinical data demonstrate EXALT™ Model D’s 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 endoscopic retrograde cholangiopancreatography (ERCP) procedures. Explore the data and get physician perspectives about high-risk patient selection.

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91.3%

procedural success rate with a single-use duodenoscope in an international, multi-site evaluation of over 550 procedures1

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7

peer-reviewed, published studies1-7

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1,100

patients 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

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60-patient consecutive series in the United States 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

Dr. Muthusamy.

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 U.S. for indications including pancreaticobiliary stone clearance, stent placement, exchange and/or removal, and balloon dilation.2

In the study

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100%

of ERCP procedures were successfully performed

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96.7%

of ERCP procedures were completed with EXALT Model D alone (3.3% with crossover to a reusable duodenoscope)

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9/10

median overall physician satisfaction for EXALT Model D

Read full article

Dr. Muthusamy is a paid consultant for Boston Scientific.

EXALT Model D clinical trial evaluation

Dr. Kenneth Binmoeller discusses the clinical evaluation of EXALT Model D and how it helps support the readiness of the device for clinical use.

Dr. Binmoeller is a paid consultant for Boston Scientific.

Get more clinical data – and make EXALT Model D an essential part of your ERCP toolkit

Talk to a rep

EXALT Model D clinical articles

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Bang JY, et al. | Gut 2020

Equivalent performance of single-use and reusable duodenoscopes in a randomized trial3

This randomized trial of 98 patients compared the performance of EXALT Model D Single-Use Duodenoscope with reusable duodenoscopes in patients undergoing ERCP.

  • Overall technical performance and safety profile were similar between EXALT Model D and reusable duodenoscopes.
  • 46 out of 48 patients were successfully cannulated using EXALT Model D.
  • Median number of attempts to achieve successful cannulation was significantly lower for EXALT Model D as compared to reusable duodenoscopes.
Real full article

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Napolean B, et al. | Digestive Endoscopy 2022

Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national 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 duodenoscope by physicians was 9 out of 10.
  • Demonstrates EXALT Model D's pre-market clinical trial results can be independently reproduced.
Read full article

Physician perspectives

Clinical 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 whitepaper

Dr. Kenneth Binmoeller

How do we start with high-risk patient selection?

Dr. Kenneth Binmoeller discusses how to start – and the path forward for using disposable duodenoscopes. 

Dr. Binmoeller is a paid consultant for Boston Scientific.

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 duodenoscope if not adopting for all patients. 

Professor Repici is a paid consultant for Boston Scientific.

Connect with a rep

Let’s discuss how to make EXALT Model D an essential part of your ERCP toolkit.

Talk to a rep

*As defined by the American Society for Gastrointestinal Endoscopy.

**Median overall satisfaction with the single-use duodenoscope was 8.0 (scale of 1 to 10) [best]

1. Bruno MJ, Beyna T, Carr-Locke D, et al. Global prospective case series of ERCPs using a single-use duodenoscope. Endoscopy. 2023;55:1103–1114. Sponsored in part by Boston Scientific.

2. Muthusamy VR, Bruno MJ, Kozarek RA, et al. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2020;18:2108–2117.e3.

Sponsored in part by Boston Scientific.

3. Bang JY, Hawes R, Varadarajulu S. Equivalent performance of single-use and reusable duodenoscopes in a randomised trial. Gut. 2021;70:838–844.

4. Napoléon B, Gonzel JM, Grandval P, et al. Evaluation of the performances of a single-use duodenoscope: prospective multi-center national study. Dig Endosc. 2022;34:215–221.

5. Slivka A, Ross AS, Sejpal DV, et al. Single-use duodenoscope for ERCP performed by endoscopists with a range of experience in procedures of variable complexity. Gastrointest Endosc. 2021;94:1046–1055.

6. Shahid HM, Bareket R, Tyberg A, et al. Comparing the safety and efficacy of two commercially available single-use duodenoscopes. J Clin Gastroenterol. 2023;57:798–803.

7. Persyn D, Van Malenstein H, Vanderschuren E, et al. Performance and applicability of a first generation single-use duodenoscope: a single-center cohort study. Ann Gastroenterol. 2022;35:368–375.

Sponsored in part by Boston Scientific.


Results from different clinical investigations are not directly comparable. Information provided for educational purposes only.


Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.