Technology | Interventional Radiology | August 14, 2019

FDA Clears NvisionVLE Imaging System for Pancreatic and Biliary Applications

New application follows previous clearance of optical coherence tomography system for esophageal applications

FDA Clears NvisionVLE Imaging System for Pancreatic and Biliary Applications

Image courtesy of NinePoint Medical

August 14, 2019 — NinePoint Medical Inc. announced it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE Imaging System for use in the pancreas and bile duct. These anatomical indications add to the previously existing esophageal applications for NinePoint’s optical coherence tomography (OCT) imaging platform.

The NvisionVLE Imaging System provides physicians real-time, high-resolution volumetric images of the tissue surface and subsurface. This allows gastroenterologists to thoroughly evaluate tissue for regions of interest that may not be visible with other medical imaging technologies. The newly cleared application is associated with NinePoint’s Low-Profile Optical Probe, a 7 French diameter imaging probe designed to handle small and tortuous anatomies, such as those found in the pancreatico-biliary system. In the pancreas and bile duct, the ability to see beneath the tissue surface could help physicians answer a number of important clinical questions.

“When a patient enters our care with an undiagnosed condition in the pancreatico-biliary system, the stakes can be very high,” said Isaac Raijman, M.D., previously the chief of gastroenterology at Baylor St. Luke’s Medical Center. “We have a number of tools today to help evaluate a patient’s condition within this anatomy. Unfortunately in many cases, our current toolset is unable to provide enough information to determine the best course of action. This is especially concerning for strictures or blockages of unknown origin. We are hopeful and excited that imaging beneath the surface with the NinePoint technology will supply the missing link and will enhance our clinical decision-making for these critically ill patients.”

This clearance marks another significant step for the strategic collaboration between NinePoint Medical and their exclusive worldwide distributor, Merit Medical Systems Inc. 

The pancreatico-biliary clearance marks a productive 12 months of product development activity for NinePoint Medical, according to the company. In November of 2018, NinePoint announced the first FDA-cleared artificial intelligence imaging technology for gastroenterology applications, the Intelligent Real-time Image Segmentation (IRIS) product. 

For more information: www.ninepointmedical.com

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