EXALT Model D Single-Use Duodenoscope Generation 3

Proven success with
peer-reviewed,
published clinical data

EXALTTM Model D Single-Use Duodenoscope Generation 3  / Clinical Data

 

Substantial clinical data proves feasibility, safety and performance

EXALT™ Model D Single-Use Duodenoscope has six peer-reviewed, published clinical trials – including four 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.
92% procedural success rate, 6 peer-reviewed clinical trials, 549 patients across all ASGE complexity grades
  

Clinically proven results for EXALT Model D

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60-patient consecutive series in U.S. resulting in 58/60 successful ERCP procedures with a single-use duodenoscope alone.1
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Randomized head-to-head trial against market-leading reusable duodenoscope demonstrating overall safety profile and similar technical performance.2
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201-patient head-to-head comparison with a competing duodenoscope showing a 54.5% lower crossover rate (10% vs. 22%).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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52-patient consecutive series showing 95.3% of ratings were neutral in comparison to a reusable duodenoscope (141/148).6
  

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.1

  
Dr. Muthusamy, gastroenterologist in white lab coat
 
      

100%
    of ERCP procedures were successfully performed
     
   

96.7%
    of ERCP procedures were completed with EXALT Model D alone (3.3% with  crossover to a reusable duodenoscope)
     
   

9/10
    median overall physician satisfaction for the EXALT Model D
     

Read the full article

   

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.

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“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 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.
   
Read the full article
   

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.
   

Physician perspectives

 
  
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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 physician perspectives on patient selection for EXALT Model D and why it may make a clinically appropriate choice for immunocompromised patients. 

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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