Waterproof Leadless Armband For Continuous Wireless Monitoring For Atrial Fibrillation

PROJECT SUMMARY ABSTRACT No longer than lines of text Atrial Fibrillation AF is the most common sustained dysrhythmia worldwide Although new AF treatment strategies have emerged over the last decade a major challenge facing clinicians and researchers is the paroxysmal often short lived and frequently asymptomatic nature of AF Paroxysmal and asymptomatic AF would be found in a growing percentage of our population if it were detectable and causes major long term health consequences despite being so silent There is therefore a pressing need to develop an inexpensive device for long term continuous monitoring containing an accurate real time AF detection algorithm to lower our nationandapos s healthcare costs Such a device would not only increase rates of detection in symptomatic patients and allow for better evaluation of treatment efficacy but could become widely adopted enough to flush out asymptomatic people if coupled with a strong awareness campaign Given the ever growing popularity of wearable devices our approach to AF detection using leadless wearable armbands and a smartphone app will give patients as well as health care providers the opportunity to monitor for AF under the wide variety of conditions in a patientandapos s real life We want to make a device the user can truly live in long term Because our approach does not involve ECG leads it will be minimally obtrusive thereby leading to better acceptance and use by patients Our wearable device has the potential to disrupt the traditional delivery of AF healthcare For this objective to be successfully achieved four key technology pillars must be commercialized The first is an accurate AF detection algorithm The second is a reusable rugged flexible electrode material that does not cause skin irritation with prolonged use in all real world conditions The third is an accurate motion artifact removal algorithm The fourth is leadless ECG capture The first two technological developments have been achieved by our companyandapos s CTO Our AF algorithm has been shown to be accurate in multiple peer reviewed publications and is now commercially available in a Holter monitor from Scottcare Corporation We have also developed novel waterproof flexible gel less reusable electrodes that do not cause skin irritation Hence the objective of this SBIR project is to bring to maturity the last two pillar technologies Preliminary work on concepts for both show great promise We believe this work will result in rapid translation in later Phases into an innovative and disruptive AF detection product The envisioned product has the potential to significantly reduce healthcare costs by accurately and more succinctly establishing the diagnosis of AF in at risk groups thereby providing clinicians with an opportunity to prevent expensive secondary complications of these life threatening arrhythmias Project Narrative We propose to develop a continuously worn leadless armband based ECG device for detecting arrhythmia including atrial fibrillation AF which is the most common arrhythmia encountered in the United States Monitoring for AF is important because even when this arrhythmia is minimally symptomatic and paroxysmal it is a major cause of disability and death among Americans Implementation of arrhythmia monitoring including AF using a wearable device people can live in will lead to a more patient friendly and timely means of arrhythmia diagnosis and has the potential to reduce healthcare costs