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EXALT™ Model D Single-use Duodenoscope
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For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N°2011-2012 dated 29th December 2011 article 34. Other health care professionals should select their country in the top right corner of the website.
Please note that the following pages are exclusively reserved for health care professionals in countries with applicable health authority product registrations. To the extent this site contains information, reference guides and databases intended for use by licensed medical professionals, such materials are not intended to offer professional medical advice. Prior to use, please consult device labeling for prescriptive information and operating instructions.
ProductPage
Dr. Brian Dunkin, Chief Medical Officer,
EXALT™ Model D Single-Use Duodenoscope
Raise the standard of patient care with EXALT Model D, the world’s first single-use duodenoscope. Designed to provide the same high performance you expect from a reusable scope in a groundbreaking single-use form, EXALT Model D eliminates infection risk due to cross-contamination from ineffective reprocessing while also reducing associated operational cost for endoscopic retrograde cholangiopancreatography (ERCP) procedures.
Clinical Data: Peer-reviewed trials
Review the data per peer-reviewed, published data and hear what leading physicians have to say about the results.
See the data
Built for performance
EXALT Model D offers the performance, control and maneuverability you need in a single-use platform.
Reduced infection risk
EXALT Model D helps reduce contamination and infection risk due to ineffective duodenoscope reprocessing.
Simple integration
Our team makes it easy to install and integrate EXALT Model D into your facilityand your practice
ENDO-790004-AD
Patient profiles that may benefit from a single-use duodenoscope
Understanding the risk factors that facilitate the transmission of infectious agents is important for preventing their spread and can also be used to identify those patients most vulnerable to infection.
This publication helps to better understand the factors that may impact a patient’s risk for infection during ERCP.
With respect to patient infection and/or colonisation associated with ERCP procedures, there are two significant pathogen reservoirs, the patient and the duodenoscope.
Segmenting ERCP patients by infection risk allows endoscopists to make more informed decisions about the risk-benefit ratio of using enhanced duodenoscope technology in the care of their patients.
Download patient risk factor overview
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Dr. Alessandro Fugazza
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Prof. J. Enrique Domínguez Muñoz
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Prof. J. Enrique Domínguez Muñoz
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Prof. J. Enrique Domínguez Muñoz
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Education & Training with EDUCARE
Our easily accessible educational platform, EDUCARE, offers you a personalised suite to support your medical education requirements.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.
Physician perspectives
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Dr. Kenneth Binmoeller
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Professor Alessandro Repici
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Reducing duodenoscope infection risk
Despite adherence to rigorous disinfection and reprocessing protocols, multiple infection outbreaks worldwide have been linked to contaminated duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Single-Use Duodenoscope completely eliminates the risk of patient infection due to ineffective reprocessing.
Complex cleaning processes increase post-ERCP infection risk
From pre-cleaning to drying, there can be more than 100 distinct steps to reprocessing a reusable duodenoscope—all of which introduce the opportunity for patient cross-contamination. Only a disposable duodenoscope like EXALT Model D eliminates the risks of cross-contamination associated with ineffective reprocessing.
Single-use duodenoscope vs. single-use endcaps
New clinical endoscopy technologies such as single-use endcaps and single-use duodenoscopes are designed to help reduce the risk of cross-contamination due to ineffective reprocessing. However, only single-use or disposable duodenoscopes, like the EXALT Model D, completely reduce the post-ERCP infection risks as a result of cross-contamination due to ineffective reprocessing.
| Benefit* | Exalt Model D | Single-Use Endcaps |
| Eliminates risk of patient infection due to ineffective reprocessing | Yes | No |
| Eliminates duodenoscope reprocessing training and compliance | Yes | No |
| Decreases waste from reprocessing such as disinfecting consumables | Yes | No |
| Enhances infection prevention efforts | Yes | Yes |
*As compared to reusable duodenoscopes. Assumes full conversion of all ERCP procedures using reusable duodenoscopes to instead using the EXALT Model D Duodenoscope.
Meta-analysis of reusable duodenoscope contamination1
A meta-analysis of 15 studies found that neither double high-level disinfection (HLD) nor ethylene oxide (EtO) gas sterilization eliminated the risk of contamination in reusable duodenoscopes that were considered patient ready.
15 Studies
13,112 Patient-ready duodenoscope
15.25% Contamination rate
Duodenoscope safety communications
The environment, equipment and guidelines that inform cleaning procedures are constantly changing, putting duodenoscope reprocessing into a state of transition.
In Europe, ESGE and ESGENA collaborated in 2019 to produce Position Statement on this topic, stressing that regardless of duodenoscope design, there are two crucial points:13
- Standardized and validated duodenoscope reprocessing should be performed by appropriately trained, dedicated, and competent staff;
- Microbiological surveillance and regular maintenance of duodenoscopes should be performed to identify any problems at an early stage.
In the United States, FDA recommended in 2019 to transition to duodenoscopes with innovative designs that range from disposable endcaps to fully disposable duodenoscopes.1
Physician perspectives
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Dr. Kenneth Binmoeller
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Dr. Kenneth Binmoeller
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Dr. Kenneth Binmoeller
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FDA Mandated surveillance studies 2, 3, 4
Due to a growing concern over the post-ERCP infection risks with reusable scopes, the FDA mandated post-market surveillance studies to monitor the effectiveness of duodenoscope reprocessing.
High-concern organisms
5.0% (1 out of 20) of properly collected samples tested positive for high-concern organisms, which cause infectious diseases
Low-concern organisms
4.4% of properly collected samples tested positive for enough low-concern organisms to indicate a reprocessing failure
Reference
1. Larsen S, Russell RV, Ockert LK, Spanos S, Travis HS, Ehlers LH, Maerkedhal A, Rate and impact of duodenoscope contamination: A systematic review and meta-analysis, EClinicalMedicine, 2020 Jul 15;25:100451, doi: 10.1016/j.eclinm.2020.100451. PMID: 32954234
2. Olympus 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=354&c_id=3726
3. Fujinim 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=353&c_id=3725
4. Pentax 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=355&c_id=3727
All trademarks are the property of their respective owners. © 2021 All images owned by Boston Scientific.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
Dr. Binmoeller is a paid consultant of Boston Scientific.
1. Larsen S, Russell RV, Ockert LK, Spanos S, Travis HS, Ehlers LH, Maerkedhal A, Rate and impact of duodenoscope contamination: A systematic review and meta-analysis, EClinicalMedicine, 2020 Jul 15;25:100451, doi: 10.1016/j.eclinm.2020.100451. PMID: 32954234
2. Olympus 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=354&c_id=3726
3. Fujinim 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=353&c_id=3725
4. Pentax 522 site: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm?t_id=355&c_id=3727
All trademarks are the property of their respective owners. © 2021 All images owned by Boston Scientific.
CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
Dr. Binmoeller is a paid consultant of Boston Scientific.
Integrating EXALT Model D with your current systems
Whether your facility is interested in full or partial adoption of EXALT Model D, our team of Customer Integration Coordinators helps ensure compatibility with major endoscope manufacturers, including SpyGlass™ DS II System, Endoscopic Ultrasound and most medical writing software.
Installation Support
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Virtual installation support demonstrationWatch a Boston Scientific technician demonstrate how we can use virtual technology to install the EXALT Model D System. Due to ongoing COVID-19 precautions, we’re using merged reality to provide remote installation and technical assistance. |
Virtual installation programDue to ongoing COVID-19 precautions, we’re using merged reality to provide remote installation and technical assistance. This innovative tool allows our remote support team to:
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A new, sterile device for each patient, delivered to you with a familiar duodenoscope design and function that forgoes the need for reprocessing.
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Product Documents
Instructions for Use
Check product packaging for detailed instructions. Need more assistance?
Reach out to our technical team for more support.
Reach out to our technical team for more support.
Technical specifications
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Substantial clinical data has been published for the EXALT™ 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.
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
100%
100% of ERCP procedures were successfully performed96.7%
96.7% of ERCP procedures were completed with EXALT Model D alone and 3.3% with crossover to a reusable duodenoscope9/10
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
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.
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EXALTTM Model D case studies
EXALT Model D is the world’s first single-use duodenoscope for endoscopic retrograde cholangiopancreatography (ERCP) procedures to be used across all ASGE complexity grades. Watch the case footage below to see how EXALT Model D offers maneuverability, stability and control in a wide variety of ERCP procedures.
Dr. Quin Liu of Cedars Sinai Medical Center uses EXALT Model D to perform an ERCP with stent exchange for a patient with history of liver transplant and resulting ischemic strictures. Model D was selected due to the patient’s history of antibiotic resistant bacteremia.
Dr. Jeremy Barber of Spectrum Health uses EXALT Model D in a patient with a history of unresectable pancreatic cancer presenting with cholangitis secondary to an obstructed biliary stent.
Case study library
 Dr. Thaker Presents Case Footage using EXALT Model D Single-Use Duodenoscope Dr. Adarsh Thaker, Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, shares case footage of two ERCP procedures demonstrating the control and maneuverability of the EXALT Model D Single-Use Duodenoscope. The first case shows scope passage into the duodenum of a patient in the prone position and the second case demonstrates how EXALT Model D maneuvers in difficult or angulated strictures. |
Dr. Shyam Varadarajulu of Orlando Hospital uses EXALT Model D to cannulate the dorsal pancreatic duct and places a stent to treat a 63-year-old female patient with recurrent acute pancreatitis. |
Dr. Shyam Varadarajulu uses EXALT Model D and the SpyGlass™ DS Direct Visualization System during an ERCP procedure on a 48-year-old woman to diagnose cholangiocarcinoma in a biliary stricture. |
Dr. Adarsh Thaker, Assistant Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, presents case footage demonstrating scope passage into the duodenum of a patient in the prone position. EXALT Model D is then used on a second patient with multi-focal biliary obstruction. |
Dr. Shyam Varadarajulu presents case footage using EXALT Model D for a biliary stent replacement in an 85-year-old woman with cholangiocarcinoma and obstructive jaundice. |
Dr. Frizzell shares the case of an ERCP procedure using the EXALT Model D Single-Use Duodenoscope with SpyGlass™ DS Direct Visualization in an 86-year-old woman with a history of extended spectrum beta-lactamases Escherichia coli cholangitis due to a retained common bile duct (CBD) stent. |
Video case report from Dr. Reddy et al. published in VideoGIE. In this ERCP procedure the EXALT Model D Single-Use Duodenoscope was used with SpyGlass DS Direct Visualization in a 98-year-old man with difficult bile duct stones. |
Minor papilla cannulation using single-use duodenoscope
All images taken by Boston Scientific. All trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
