Per professionisti sanitari in EUROPA a eccezione di coloro che praticano in Francia, in quanto le seguenti pagine sono destinate a tutti i professionisti sanitari a livello internazionale e non sono conformi alla legge francese sulla pubblicità n. 2011-2012 del 29 dicembre 2011, articolo 34. Gli altri professionisti sanitari sono tenuti a selezionare il Paese di pertinenza nell'angolo in alto a destra del sito Web.
Si noti che le seguenti pagine sono riservate esclusivamente ai professionisti sanitari dei Paesi per i quali esistono le necessarie registrazioni dei prodotti presso le autorità sanitarie competenti. Nella misura in cui questo sito contiene informazioni, guide di riferimento e database destinati all'uso da parte di professionisti medici autorizzati, tali materiali non costituiscono raccomandazioni mediche professionali. Prima dell'uso consultare l'etichettatura del dispositivo per informazioni di prescrizione e istruzioni per il funzionamento.
Un dispositivo sterile nuovo per ogni paziente, dotato di design e funzioni del duodenoscopio familiari che elimina la necessità di ritrattamento.
Codice prodotto:
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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
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. 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
This randomised trial of 98 patients compared the performance of the EXALT Model D Single-Use Duodenoscope with reusable duodenoscopes in patients undergoing ERCP.
Napolean N, et al. | Digestive Endoscopy 2021
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.
ENDO-869304-AE
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.
 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. |
Tutte le immagini sono state realizzate da Boston Scientific. Tutti i marchi commerciali appartengono ai legittimi proprietari. ATTENZIONE: la legge limita la vendita di questi dispositivi esclusivamente a medici o su prescrizione medica. Indicazioni, controindicazioni, avvertenze e istruzioni per l’uso sono riportate nell'etichetta del prodotto fornita con ciascun dispositivo. Queste informazioni possono essere utilizzate esclusivamente nei Paesi in cui il prodotto è stato registrato presso le autorità sanitarie competenti. Questo materiale non è destinato all'uso in Francia. I prodotti sono mostrati esclusivamente a scopo INFORMATIVO e potrebbero non essere approvati o in vendita in determinati Paesi. Si prega di verificare la disponibilità contattando il rappresentante di vendita o l’assistenza clienti di zona.
Minor papilla cannulation using single-use duodenoscope
