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.
Diversatek Abandons Trademark Application For MiVu® After Opposition Proceedings
MiVu® Mucosal Integrity Testing System only from Diversatek Healthcare
Diversatek Healthcare MiVu® Product Launch
MiVu® Mucosal Integrity Testing System Announced December 2, 2020
“MiVu® is the first mucosal integrity (MI) testing system for rapid diagnosis of gastroesophageal reflux disease (GERD), eosinophilic oesophagitis (EoE) and Non-GERD, as well as monitor treatment response in patients with GERD and EoE.”
“MiVu® is the first mucosal integrity (MI) testing system for rapid diagnosis of gastroesophageal reflux disease (GERD), eosinophilic oesophagitis (EoE) and Non-GERD, as well as monitor treatment response in patients with GERD and EoE.
Developed by Diversatek Healthcare in collaboration with Vanderbilt University, MiVu® detects oesophageal mucosal changes during a routine endoscopy, indicating the presence or likelihood of GERD and other oesophageal conditions in two minutes.
In December 2020, the US Food and Drug Administration (FDA) cleared the testing system with De Novo classification due to its safety and efficacy profile in obtaining electrical properties measurements within the oesophageal tissue.
MiVu® testing system details
MiVu® uses a balloon probe and proprietary software to measure oesophageal epithelium conductivity directly and provides a mucosal integrity contour pattern and disease probability to clinicians.
The MiVu® balloon probe of the system is a single-use, disposable supply that meets the requirements of the CMS as a separately reportable supply device. It incorporates both radial and axial impedance sensors mounted at 180° intervals in a 10cm section of the oesophagus that evaluate mucosal integrity and provide real-time impedance values, reducing variability in measurement.
Real-time detection via MiVu® during a routine endoscopy potentially eliminates the need for 24 hours to 48 hours ambulatory pH or histopathological oesophageal biopsies to reduce both diagnosis and treatment latency.
Limitations with current testing methods
Key diagnostic techniques currently used for suspected GERD are endoscopy and ambulatory reflux monitoring, which are widely used but have major drawbacks that result in an ambiguous and questionable diagnosis inaccurate in determining therapy for diagnosed patients.
Oesophageal mucosal inflammation detected by endoscopic assessment is present in less than 30% of patients.”
Read more here: MiVu Diversatek
Healthcare - Diversatek Healthcare Announces MiVu® M.I. Device, December 2, 2020
December 2, 2020·3 min read
MILWAUKEE, Dec. 2, 2020 /PRNewswire/ -- “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.
MiVu® utilizes a balloon probe and proprietary software to measure the conductivity of the esophageal epithelium directly.
MiVu® is the only system available that provides real-time data of mucosal integrity during routine endoscopy.
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."
Read the story here: MiVu Diversatek