Healthcare professionals / Gastroenterology / EXALTTM Model D Single-Use Duodenoscope

EXALTTM Model D Single-Use Duodenoscope

Changing the standard of care for ERCP procedures with the world’s first and only single-use, sterile duodenoscope designed to be lightweight, consistent and high-performing.
Duodenoscope reprocessing is in a period of rapid transition and new technologies are required to make reprocessing safer, easier or unnecessary. In response, Boston Scientific has developed EXALT Model D, the world's first single use, sterile duodenoscope to help preserve a patient's access to life-saving medical care. 
EXALT Model D allows a physician to start each ERCP with a brand new duodenoscope and completely eliminates the need for reprocessing.

 
Familiar performance

Familiar Performance

 

“With the EXALT Model D Duodenoscope, I can perform the same high-quality ERCP procedure with the added benefit of using a brand-new sterile device for each patient, thereby avoiding any cross-patient contamination and infection risk.” – Professor Marco Bruno, Professor of Gastroenterology & Hepatology, Head of the Department of Gastroenterology & Hepatology, Erasmus Medical Center, University Medical Center Rotterdam, The Netherlands

 
 
   

Clinically Proven



Exalt USA.

60

Human use clinical trial patients

In a consecutive case series of the EXALT Model D Duodenoscope, 60 ERCPs, of all 4 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

EXALT Scope.

96.7%

ERCP procedures completed with EXALT alone

All ERCP procedures were successfully performed, of which 96.7% were completed with the single-use duodenoscope alone and 3.3% with crossover to a reusable duodenoscope.

Exalt Social.

9/10

Median overall satisfaction
with EXALT

The median overall satisfaction with the
single-use duodenoscope by phisicians was rated a 9 out of 10

1Muthusamy VR1, Bruno MJ, Kozarek RA3, Petersen BT4, Pleskow DK5, Sejpal DV6, Slivka A7, Peetermans JA8, Rousseau MJ8, Tirrell GP8, Ross AS3. Clinical evaluation of a single-use duodenoscope for endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2019 Nov 6. pii: S1542-3565(19)31261-3. doi: 10.1016/j.cgh.2019.10.052. [Epub ahead of print]


Duodenoscope Safety Communications 


 

The environment, equipment and guidelines that inform cleaning procedures are constantly changing putting duodenoscope reprocessing into a state of transition. Reprocessing is constantly becoming more complex and resource intensive, yet can still leave devices contaminated.2

Duodenoscope reprocessing manuals are complex and can average3

In one study focused on adherence to reprocessing guidelines, only 1,4% of trained staff performed the reprocessing steps correctly.

Recently, ESGE and ESGENA collaborated to produce Position Statement on this topic, stressing that regardless of duodenoscope design, there are two crucial points:4

- 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.

2Ofstead CL, Wetzler HP, Snyder AK, Horton RA. Endoscope Reprocessing Methods: A Prospective Study on the Impact of Human Factors and Automation. Gastroenterol Nurs. 2010; 33(4): 304-311.
3Olympus Reprocessing Manual
4 Statement of the European Society of Gastroenterology and Endoscopy Nurses and Associates: European Curriculum for endoscope reprocessing. November 2019. esgena.org

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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.Product available in the European Economic Area (EEA) only. Please check availability with your local sales representative or customer service.

All photographs taken by Boston Scientific.

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