The NvisionVLE Imaging System, with Advanced OCT, uses an optical signal acquisition and processing method to create more complete cross-sectional images—letting you evaluate 100% of the tissue in a 6cm scan to better inform your evaluation. 3mm deep. 6cm long. At a resolution of 7 microns. In real time. So you can do more than just look. You can see.
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. The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specific disease has not been evaluated.
The NvisionVLE Imaging System allows clinicians to evaluate the esophageal tissue microstructure in a groundbreaking manner, during a standard endoscopy procedure. The system performs a cross sectional scan through a 6cm length, 3mm deep, enabling visualization of tissue layers including the squamous mucosa, submucosa, and muscularis propria, as well as identification of suspicious areas within the tissue. All so you can provide a more thorough evaluation—potentially leading to improved biopsy targeting for diagnosis by histopathology and more complete information to determine the best treatment for your patients.
The NvisionVLE Imaging System creates 1,200 cross-sectional images, in real time, as it scans the targeted segment of the esophagus over a length of 6cm. Each of these full cross-sections, penetrating approximately 3mm into the esophageal tissue, can easily be explored here.
In addition to circumferential cross-sections, you can view a cross-section of the esophageal wall along the axis of the organ. The NvisionVLE Imaging System creates over 4,000 longitudinal images of the esophagus in one 90-second scan, each of which can be explored here.
For close examination of a particular area of interest, either within the cross-sectional or longitudinal views, these windows provide a magnified view.
As you manipulate the cross-sectional or longitudinal views on the NvisionVLE touch-screen monitor, each of the corresponding views update smoothly and in real time.
The NvisionVLE Imaging Console is designed with clinicians in mind:
The NvisionVLE User Interface is designed for flexibility and functionality:
The NvisionVLE Imaging System utilizes a single-use optical probe and lens system that rotates at high speed while retracting within the inner lumen.
The Current Procedural Terminology (CPT)* codes used for reimbursement of the VLE procedure are:
CPT 43206 Esophagoscopy, flexible, transoral; optical endomicroscopy
CPT 43252 Esophagogastroduodenoscopy, flexible, transoral; optical endomicroscopy
Both of these codes for upper GI procedures have been assigned to APC 419 for Hospital Outpatient Facility Reimbursement.
CPT 88375 Optical endomicroscopic image(s), interpretation and report, real-time or referred, each endoscopic session
This code, intended for the pathologist, has been assigned to APC 0342 for Hospital Outpatient Facility Reimbursement.
To receive the NvisionVLE™ Imaging System Reimbursement Guide, pleaseask your local NinePoint Medical representative.
For more information about reimbursement, please contact us at firstname.lastname@example.org.
* CPT codes and descriptions only are copyright 2013 American Medical Association (AMA). All rights reserved. The AMA assumes no liability for data contained or not contained herein.
The coding, coverage, and payment information contained herein is gathered from various resources and is subject to change without notice. Nine Point Medical cannot guarantee success in obtaining third-party insurance payments. Third-party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Providers should contact their third-party payers for specific information on their coding, coverage, and payment policies.
NinePoint’s NvisionVLE Imaging System is a groundbreaking convergence of superior optical imaging, innovative engineering techniques, and revolutionary information technology. At the heart of the system, Advanced Optical Coherence Tomography (OCT) technology provides physicians and pathologists with comprehensive, volumetric digital images of a patient’s esophagus. This next-generation technique enables much higher imaging speeds, combined with improved field-of-view and signal-to-noise ratio.
The (greatly simplified) fundamentals of Advanced OCT are shown in the above diagram. Similar to a traditional laser, the swept-source laser produces light of only one ‘color’ at any instant in time. However, unlike a traditional laser, the swept-source changes the color of its output light very rapidly in time.
The output light is split in two: one beam stays internal to the console, while the second is transmitted through the catheter and focused into the tissue. Some of the light is reflected back from physiological structures within the tissue, and this reflected light is collected by the catheter and returned to the console.
Inside the console, the reflected and internal beams are combined and interfere with each other. After some processing, the interference signal yields an axial line (‘A-line’) that records the intensity of reflections at each depth in the tissue. Combining many consecutive A-lines into an image provides a cross-sectional look at all the reflecting structures in the tissue.
The basic principles of Optical Coherence Tomography (OCT) were initially used within the fields of optical radar and optical telecommunications, among others. The technology expanded in the late 1980s when researchers began exploring applications for biological tissue imaging. Over the next decade, researchers around the world developed sub-categories of the technology, such as swept-source OCT, and began investigating ways to use OCT in different types of tissues and biomedical applications.
Today, commercial OCT systems are used regularly as an imaging standard in ophthalmology, cardiology, dermatology, and general research. NinePoint’s Advanced OCT technology, licensed from the Wellman Center for Photomedicine at Massachusetts General Hospital, initially focuses on esophageal and general imaging of tissue microstructure.
The ideal imaging system for esophageal surveillance would combine high-resolution scanning, depth, and volume to enable the identification and interrogation of both superficial and buried features.
NinePoint Medical is positioned to improve patient care through the development of medical devices that enable high-resolution in-vivo imaging. Using advanced optical technologies, NinePoint Medical empowers treating physicians and pathologists to image cross-sectionally to visualize features at and below the mucosal surface, over very large areas. We deliver imaging information to support clinical decision-making relative to biopsy placement and treatment planning.
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Contact: Judith Huber, Chief Financial Officer JHuber@ninepointmedical.com
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