EXALT Model D Single-Use Duodenoscope

Proven with
peer-reviewed,
published clinical data

EXALTTM Model D Single-Use Duodenoscope / Clinical Data
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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.


 
 
Substantial clinical data has been published for the EXALT Model D Single-Use Duodenoscope
  
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

 Checkmark, 100%

100%

100% of ERCP procedures were successfully performed

 Checkmark, 96.7%

96.7%

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

 Checkmark, 9/10

9/10

The median overall physician satisfaction for the EXALT Model D Single-Use duodenoscope scope by physicians was 9 out of 10

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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

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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.
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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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