Instantly view esophageal mucosal integrity during endoscopy with MiVu™ in just two minutes
MiVu™ Mucosal Integrity Testing System
Instantly view esophageal mucosal integrity during endoscopy with MiVu™ in just two minutes
A New Approach to Assessing Esophageal Mucosal Integrity.
Instantly diagnose GERD, EoE, and Non-GERD and monitor treatment response in GERD and EoE with MiVu.™
Current Testing.
Primary diagnostic tools used in practice today for suspected GERD include endoscopy and ambulatory reflux monitoring. These commonly used tools have significant limitations, resulting in many tested patients having a vague, questionable diagnosis that is not an effective guide for therapy. Esophageal mucosal injury detected by endoscopic evaluation is present in less than 30% of patients.i Currently available pH technology only measures the acidity of refluxed material at a single point along the esophagus. Furthermore, these tests fail to account for day-to-day variability of reflux, as they only provide a 24- to 48-hour snapshot of a disease process that is chronic in nature.ii Thus, current diagnostic testing in GERD is suboptimal and can have false-negative rates of nearly 30% in patients that have endoscopic esophagitis.iii iv
What is Mucosal Integrity Testing (MI)?
Mucosal Integrity is affected by the presence of dilated intercellular spaces (DIS), or spongiosis, which affects paracellular permeability of the esophageal lumen. DIS is an important histologic feature in GERD and eosinophilic esophagitis (EoE) where the degree of dilation inversely correlates with MI measurements (i.e., lower impedance values occur with increasing DIS).
Mucosal Integrity correlates inversely with spongiosis, differentiates esophageal disorders, and monitors treatment response in GERD.How is Mucosal Integrity Measured?
Diversatek Healthcare developed the MiVu™ Mucosal Integrity Testing System, which utilizes a balloon or the MiVu™ Endo Cap, along with proprietary software to instantly detect changes in esophageal mucosal integrity during endoscopy – in just two minutes.
The MiVu™ Endo Cap securely attaches to the endoscope, allowing for direct visualization of the acquisition target, reducing overall procedure time.
Real time impedance values, a mucosal integrity contour pattern and disease probability are displayed which distinguishes various esophageal pathologies (GERD, EoE, or Non-GERD).
Why MiVu?
Using esophageal mucosal integrity measurements, clinicians are able to easily differentiate certain esophageal disorders and monitor treatment response in GERD.
In those patients with nonerosive disease who had abnormal reflux by pH monitoring, MI values were similar to those with erosive esophagitis. MI was superior in predicting erosive reflux when compared to pH monitoring, with a specificity of 95% and positive predictive value of 96% compared to 64% and 40%, respectively.v Despite the lack of obvious mucosal changes at endoscopy, MI can differentiate those with abnormal reflux pattern from those with normal reflux parameters.
MI also accurately predicted EoE during endoscopy with a sensitivity of 100% and specificity of 96% without the need for histology.vi Our findings support the possibility that in vivo measurement of esophageal mucosal impedance may be an accurate means of assessing activity in a patient with EoE without the need for obtaining esophageal biopsy specimens.
MiVu™, only from Diversatek Healthcare, detects esophageal mucosal changes due to chronic GERD and EoE, and as importantly, MiVu provides objective evidence of no inflammatory disease. Detection is instant during routine endoscopy, potentially obviating the need for 24- to 48-hour ambulatory pH monitoring or esophageal biopsies for histopathology, reducing both diagnostic and treatment latency.vii
Real time impedance values, a mucosal integrity contour pattern and diseaseprobability are displayed which distinguishes various esophageal pathologies (GERD, EoE, or Non-GERD).
References
i Dent J. Gastro-oesophageal reflux disease. Digestion 1998;59: 433–445.
ii Patel DA, Vaezi MF. Utility of esophageal mucosal impedance as a diagnostic test for esophageal disease. Curr Opin Gastroenterol 2017;33:277–284.
iii Wenner J, Johansson J, Johnsson F, et al. Optimal thresholds and discriminatory power of 48-h wireless esophageal pH monitoring in the diagnosis of GERD. Am J Gastroenterol 2007;102:1862–1869.
iv Kessels SJM, Newton SS, Morona JK, et al. Safety and efficacy of wireless pH monitoring in patients suspected of gastroesophageal reflux disease: a systematic review. J Clin Gastroenterol 2017;51:777–788.
v Caroline Barrett & Yash Choksi & Michael F. Vaezi, Mucosal Impedance: a New Approach to Diagnosing Gastroesophageal Current Gastroenterology Reports (2018) 20:33 Reflux Disease and Eosinophilic Esophagitis.
vi Choksi Y, Lal P, Slaughter JC, et al. Esophageal mucosal impedance patterns discriminate patients with eosinophilic esophagitis from patients with GERD. Clin Gastroenterol Hepatol 2018;16:664–671 e1.
vii Dhyanesh A. Patel, Tina Higginbotham, James C. Slaughter, Muhammad Aslam, Elif Yuksel, David Katzka, C. Prakash Gyawali, Melina Mashi, John Pandolfino, and Michael F. Vaezi, Development and Validation of a Mucosal Impedance Contour Analysis System to Distinguish Esophageal Disorders, Gastroenterology 2019;156:1617–1626.
MiVu™ Mucosal Integrity Testing System is covered by one or more of the following patents: US 11,291,382, US 10,321,867 and US 9,814,408.