NVisionVLE
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Catalog excerpts

NVisionVLE - 2

White light endoscopy (WLE), the most widely used imaging modality for standard endoscopic examination, is limited to surface evaluation of the esophageal tissue. It is becoming increasingly recognized that esophageal abnormalities may be present below the surface where they cannot be visualized with WLE. Random biopsy is the current standard of care for diagnosing esophageal disease such as Barrett's esophagus, squamous cell carcinoma, and adenocarcinoma. However, random biopsies assess less than 3% of the esophageal surface1 leaving more than 97% of the tissue unsampled. Furthermore, even...

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NVisionVLE - 3

Advanced OCT - filling the imaging gap Endoscopic Ultrasound (EUS) has gained widespread adoption for esophageal imaging. Its strength is in staging existing tumors, but lacks resolution in the first few millimeters of tissue making it ill suited for evaluation of mucosal tissue microstructure. Confocal Laser Endomicroscopy (CLE) provides cellular detail, but doesn't have a wide enough field of view or depth of imaging to identify abnormalities that may be present below the surface. The ideal imaging system for identifying and targeting . ,.i. . . SIZE OF BUBBLE DENOTES FIELD OF VIEW...

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Breakthrough Design The NvisionVLE® Imaging System Console is designed for clinicians: O Feature-rich user interface and hand controller for intuitive navigation and high-resolution image management O Rapid set-up, easy mobility, and user-friendly controls High Speed Optical Probe The NvisionVLE® Imaging System utilizes a single-use optical probe and lens system that rotates at high speed while retracting within the inner lumen: O Balloon catheter facilitates optical probe positioning and centering, available in 1 4mm, 1 7mm, and 20mm O Also available as balloon-less 7 French Low-Profile...

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Cross-Sectional View Explore the entire targeted segment of the esophagus in real time: O Collect 1,200 cross-sectional slices O Targeted segment of 6cm O Approximafely 3mm penefrafion info esophageal fissue Longitudinal View Examine fhe plane of fhe esophagus perpendicular fo ifs cross-secfion: O View fhe esophageal wall along fhe axis of fhe organ O Over 4,000 longifudinal images of fhe esophagus ROI View For close examinafion of a particular Region of Inferesf (ROI), eifher wifhin fhe cross-secfional or longifudinal views, fhese windows provide a zoomed-in view. Provides overview of...

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Advantages of the NvisionVLE® Imaging System O Advanced OCT captures images up to 3mm beneath the mucosa at 7 micron resolution in real time, unlike WLE, which can only image surface detail O Visualize 1 00% of fhe fissue in a 6cm scan for more informed evaluafions O Offers a full-field view (—10,000mm2), as opposed fo a "poinf" image typically obtained with confocal microscopy (0.25mm2) O Advanced OCT imaging delivers up to 25X higher resolution than endoscopic ultrasound O Creates tissue laser marks visible under WLE, designed to help clinicians target biopsies at a site of interest that...

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For a demonstration of the NvisionVLE® Imaging System, contact your local Sales Representative or email vle@merit.com. Ordering Information Item Name NvisionVLE® Imaging Console with Real-time Targeting and IRIS NvisionVLE® Optical Probe 20mm Balloon 17mm Balloon 14mm Balloon Low-Profile Balloon-less NvisionVLE® Inflation System - Box of 5 Reimbursement For current information regarding reimbursement of the VLE procedure, please visit: www. ninepointmedical. com/# reimbursement or contact reimbursement.endotek@merit.com Regulatory The NvisionVLE® Imaging System has been cleared by the U.S....

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NVisionVLE - 8

Merit Medical Europe, Middle East, & Africa (EMEA) Amerikalaan 42, 6199 AE Maastricht-Airport The Netherlands + 31 43 358 82 22 Merit Medical Ireland Ltd. Parkmore Business Park West Galway, Ireland + 353 (0) 91 703 733 The NvisionVLE® Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization and may be used to mark areas of tissue. The software provides segmentation and display of common imaging features, including...

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