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.

 
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.”  — Dr. Raman Muthusamy, Medical Director of Endoscopy, Professor of Clinical Medicine, David Geffen School of Medicine at UCLA.

 
 
   

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


There have been more safety communications on duodenoscopes than any other medical device since 2013. The environment, equipment and guidelines that inform cleaning procedures are constantly changing putting duodenoscope reprocessing into a state of transition. Recently, the FDA recommended healthcare providers transition to duodenoscopes with disposable components or fully disposable devices.

EXALT Model D Single-Use Duodenoscope is a fully disposable option.

FDA.FDA safety communications
 
Guidelines.Guideline updates
 
IFU.IFU updates
 
Product recalls.Product recalls/removals

FDA Grants Breakthrough Device Designation

 

 
Designed to provide healthcare providers and patients with timely access to vital technologies, Breakthrough Device Designation has been granted by the FDA to the EXALT Model D Single-Use Duodenoscope. We're all in. For you, for your patients. 
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We're all in.
For you, for your patients.

Get up to date information on EXALTTM as well as our commitment to sustainability and clinical education.

 

All trademarks are the property of their respective owners.

 

CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.All photographs taken by Boston Scientific.

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