Koronis Biomedical Technologies Corp. — Department of Health and Human Services SBIR Phase I: N

Description

Abstract Atrial fibrillation AF is the most common arrhythmia encountered in clinical practice affecting a growing population of over million Americans Paroxysmal atrial fibrillation PAF is a self terminating form of the cardiac arrhythmia that comprises between and of AF cases It is a growing epidemic in cardiovascular disease predicted to afflict over million people in the United States alone by Advancing age is a major risk factor for the development of atrial fibrillation The prevalence of AF in people over the age of is and it exceeds in individuals over For this reason opportunistic screening of AF has been recommended in high risk individuals including people over the age of individuals over with hypertension and patients with previous stroke of uncertain etiology PAF may be a single episode or clusters of abnormal rhythms with variable duration PAF is often asymptomatic and in those patients with symptoms it has been estimated that for every symptomatic episode there are asymptomatic ones The self terminating nature of PAF leads to its frequent under diagnosis and consequent lack of use of established stroke prevention therapies The proposed wearable screening tool based upon photoplethysmography ties clinical data collected at home directly to the clinician is completely unobtrusive and does not require surgical implantation This system could identify even brief episodes of atrial fibrillation and prevent significant morbidity and mortality by identifying individuals who would benefit from therapy such as anticoagulation that significantly reduces stroke risk The innovation of this project is a low cost and practical solution for providing such screening A prototype system will be developed and evaluated human pilot study in phase Narrative More than Americans suffer from a stroke each year making it a leading cause of disability in the United States The cause remains unexplained after routine evaluation in to of cases These strokes without defined mechanisms are referred to as cryptogenic stroke