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.”

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.”