Para profesionales sanitarios de EUROPA, excepto para aquellos que ejerzan en Francia, ya que las siguientes páginas están destinadas a todos los profesionales sanitarios internacionales y no cumplen la ley de publicidad francesa n. º 2011-2012 con fecha del 29 de diciembre de 2011, artículo 34. Otros profesionales sanitarios deben seleccionar su país en la esquina superior derecha del sitio web.
Tenga en cuenta que las siguientes páginas están reservadas exclusivamente para profesionales sanitarios de países con registros de productos de la autoridad sanitaria aplicable. En la medida en que este sitio contiene información, guías de referencia y bases de datos previstas para uso por parte de profesionales médicos colegiados, dichos materiales no se han concebido para ofrecer asesoramiento médico profesional. Antes de su uso, consulte el etiquetado del dispositivo para obtener la información prescriptiva y las instrucciones de funcionamiento.
Un nuevo dispositivo estéril para cada paciente, que se le entrega con las características de diseño y funcionamiento de los duodenoscopios que le son familiares, pero sin la necesidad de reprocesamiento.
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. |
Todas las imágenes han sido realizadas por Boston Scientific. Todas las marcas comerciales son propiedad de sus respectivos dueños. PRECAUCIÓN: Las leyes solo permiten la venta de estos dispositivos bajo prescripción facultativa. Las indicaciones, contraindicaciones, advertencias e instrucciones de uso se encuentran en la etiqueta del producto suministrada con cada dispositivo. Información disponible únicamente para los países con los correspondientes registros de productos por parte de las autoridades sanitarias. Material no concebido para su uso en Francia. Estos productos se muestran únicamente con fines INFORMATIVOS y es posible que no estén aprobados o no se puedan vender en determinados países. Compruebe la disponibilidad con su representante de ventas local o con el servicio de atención al cliente.
Minor papilla cannulation using single-use duodenoscope
