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Millar reports the Mikro-Cath received 510(k) clearance for airway pressure measurements in March 2017. This newly cleared indication has enabled Dr. Richard Schwab, Professor of Medicine at the Hospital of the University of Pennsylvania, to incorporate high-fidelity pressure measurements in his sleep study to better understand the anatomical and physiological differences in patients diagnosed with obstructive sleep apnea.
The Mikro-Cath is currently being used to measure esophageal pressure changes and monitor upper airway pressures throughout the different sleep stages. The Millar catheter provides an easier way to measure pressures in these patients due to its reduced size and signal accuracy.
The catheter technology supports the physiological component of the study and can be correlated with magnetic resonance imaging (MRI) along with the evaluation of sleep arousal, muscle responsiveness, loop gain, and air collapsibility. The study will incorporate 400 patients over the next 3 to 4 years. The end goal will be to understand the anatomical and physiological differences in sleep apnea patients with high BMI and those with normal BMI.
With an estimated 22 million Americans suffering from sleep apnea, research to identify the anatomical phenotypes is important for improving new treatment going forward and to reduce risk for high blood pressure, heart attack, stroke, and arrhythmias that can result from sleep apnea.