The Endoflip™ System and its accessory catheters have US Food and Drug Administration (FDA) clearance to measure pressure and dimensions in the esophagus, pylorus and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.
Endoflip® uses a technique called high resolution impedance planimetry (IP) to characterize the geometry of the measurement area. High resolution impedance planimetry is an established technique for performing measurements of cross sectional areas in the alimentary tract.
It uses AC voltage measurements made between pairs of electrodes to estimate the extent of the diameter of the medium – a conductive fluid – at the mid-point between those electrodes. This can be done provided the voltage drop across the medium is generated from a constant AC current source and the conductivity of the medium is constant and known for a given temperature.
Endoflip® injects a specially-formulated conductive solution into a balloon catheter placed in the measurement area. The balloon contains an array of electrodes that measure voltage. Endoflip® uses these voltages to estimate the diameter at up to 16 points along the measurement area. The system allows snapshots of this data to be saved and commented for reference.