MiVu, a first-ever mucosal integrity (MI) diagnostic system from Diversatek Healthcare, was granted De Novo classification* from the Food and Drug Administration (FDA) for the safety and efficacy in obtaining measurements of electrical properties within esophageal tissue.
MiVu is the only system available to clinicians that provides real-time data of mucosal integrity during routine endoscopy, indicating the existence or probability of gastroesophageal reflux disease (GERD) and other esophageal pathologies in just two minutes.
Diversatek Healthcare, in conjunction with Vanderbilt University, developed the MiVu Mucosal Integrity Testing System to detect changes in esophageal mucosal integrity simply and efficiently.
MiVu utilizes a balloon probe and proprietary software to measure conductivity of the esophageal epithelium directly, while providing clinicians both a color contour map and predictive probability. Its unique design, incorporating both radial and axial impedance sensors, measures mucosal integrity at 180-degree intervals along a 10 cm segment of the esophagus, reducing measurement variability.
MiVu enables clinicians to quickly and efficiently rule out GERD, differentiate primary esophageal disorders like GERD and eosinophilic esophagitis (EoE), and monitor treatment response. It may eliminate the need for ambulatory reflux testing and multiple invasive biopsies.
“There is a lot of symptom overlap between GERD and EoE, said Dr. Michael Vaezi, Professor of Medicine and Otolaryngology at the Vanderbilt University Medical Center in the Division of Gastroenterology, Hepatology and Nutrition. Current diagnostic tests for esophageal disorders, which are often inconclusive, make it challenging to provide patients with reliable, timely information that adequately guides next steps. MiVu’s direct measurement provides accurate, instant data that can immediately direct therapy while helping to reduce the need for unnecessary testing.”
“After more than eight years of ongoing testing and clinical studies, we are thrilled to bring MiVu to the market,” said Diversatek Healthcare’s Chairman Brant Stanford. “Current diagnostic tools for patients experiencing chronic esophageal disorders are incapable of detecting subtle, but real, disease conditions. MiVu is a fast, effective alternative that helps guide therapy decisions and monitors disease activity over time, ultimately saving patients time and money.”
Source: Company Press Release