NinePoint Medical, a transformative medical device company pioneering the use of an advanced imaging platform for gastrointestinal applications, announced that it has completed the primary phase of its Registry for High Resolution Optical Imaging of the Esophagus Using the NvisionVLE Imaging System.
Results from the registry’s interim analysis will be presented in 11 scientific abstracts accepted to Digestive Disease Week® (DDW) 2016, to be held May 21-24 in San Diego, California.
The NvisionVLE Imaging System employs proprietary Optical Coherence Tomography (OCT) technology allowing physicians to perform a Volumetric Laser Endomicroscopy (VLE) procedure that produces real-time, high-resolution cross-sectional images.
This system enables gastroenterologists to evaluate tissue for potential disease that may not be visible with conventional medical imaging technologies such as endoscopy or ultrasound.
The initial enrollment of 1,000 patients at 18 hospitals in the U.S. has been completed. A second phase of the registry will examine longitudinal follow-up imaging of these patients. To date, over 500 such follow-up procedures have been performed.
This prospective, multi-site registry is led by Dr. Michael S. Smith, M.D., M.B.A., Medical Director of the Esophageal Program and Associate Professor of Medicine in the Gastroenterology Section of the Lewis Katz School of Medicine at Temple University in Philadelphia, Pennsylvania.
"Bringing together 18 of the leading hospitals in the U.S., we have developed the world’s largest database of esophageal OCT scans along with data evaluating the clinical impact of this technology", commented Dr. Smith.
"The data we will present at DDW 2016 show that the use of VLE to guide tissue sampling for Barrett’s esophagus increases the likelihood of finding advanced disease compared to random biopsies, which is the current standard of care."
"This registry has been very beneficial in helping us understand how our customers are using VLE, and the clinical impact they have observed", commented Christopher R. von Jako, Ph.D., President and CEO of NinePoint Medical.
"In over half of the procedures, physicians found areas of suspicion with VLE that were not found with standard imaging, and this information was used both to target biopsies and to guide treatment of disease."
Esophageal adenocarcinoma (EAC) is the fastest growing cancer in the western world, increasing in incidence more than 7-fold over the past several decades.1 Barrett’s esophagus, a complication of gastroesophageal reflux disease (GERD), affects more than 12 million American adults,2 and is associated with a 30-fold increased risk of developing EAC.3
The NvisionVLE Imaging System provides a unique and clinically valuable new perspective of esophageal disease: The ability to image within the wall of the esophagus.
By providing a high-resolution, real-time scan of the esophagus using Optical Coherence Tomography (OCT) – a technology similar to ultrasound but using infrared light rather than sound waves – the system enables physicians to view structures not evident with conventional imaging, and potentially identify disease that would have otherwise been missed.
With the recent addition of a Real-time Targeting feature, physicians can not only locate, but now mark areas of interest. This marking feature, in combination with an improved workflow, enables more accurate targeting, potentially leading to improved diagnosis and more effective therapeutic decisions for patients.
The NvisionVLE® Imaging System has been cleared by the FDA and is commercially available in the U.S.