A new, sterile device for each patient, delivered to you with a familiar duodenoscope design and function that forgoes the need for reprocessing.
Model: Single-use Duodenoscope
Package Quantity: 1
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Product Code: M0054242CE0
Add to Product List Remove from Product List- EXALT™ Model D Single-use Duodenoscope
- GTIN:08714729995746
- Model:Single-use Duodenoscope
- Package Quantity:1
- EXALT™ Model D Single-use Duodenoscope
- GTIN:08714729995746
- Model:Single-use Duodenoscope
- Package Quantity:1
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Technical specifications
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Model
Package Quantity
EXALT™ Model D Single-use Duodenoscope
M0054242CE0Model
Single-use Duodenoscope
Package Quantity
1
GTIN
08714729995746
EXALT™ Model D Single-use Duodenoscope
M0054242CE1Model
Single-use Duodenoscope
Package Quantity
2
GTIN
08714729995753
EXALT™ Controller
M00542430Model
Controller - English, Spanish, French, German, Italian, Dutch and Portuguese
Package Quantity
1
GTIN
08714729990901
EXALT™ Model D Controller
M00542460Model
Controller - English, Danish, Greek, Portuguese-Brazil, Swedish, Hungarian, Czech, Polish, Norwegian, Korean, Turkish, Finnish, Romanian and Slovak
Package Quantity
1
GTIN
08714729993612
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.
ENDO-869304-AE
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
