Waterproof Leadless Armband For Continuous Wireless Monitoring For Atrial Fibrillation

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1 PROJECT SUMMARY/ABSTRACT 2 (No longer than 30 lines of text) 3 Atrial Fibrillation (AF) is the most common sustained dysrhythmia worldwide. Although new AF 4 treatment strategies have emerged over the last decade, a major challenge facing clinicians and 5 researchers is the paroxysmal, often short-lived, and frequently asymptomatic nature of AF. Paroxysmal 6 and asymptomatic AF would be found in a growing percentage of our population if it were detectable, and 7 causes major long-term health consequences despite being so silent. There is, therefore, a pressing need to 8 develop an inexpensive device for long-term, continuous monitoring containing an accurate real-time AF 9 detection algorithm, to lower our nation's healthcare costs. Such a device would not only increase rates of 10 detection in symptomatic patients and allow for better evaluation of treatment efficacy, but could become 11 widely-adopted enough to flush out asymptomatic people, if coupled with a strong awareness campaign. 12 Given the ever-growing popularity of wearable devices, our approach to AF detection using leadless 13 wearable armbands and a smartphone app will give patients as well as health care providers the 14 opportunity to monitor for AF under the wide variety of conditions in a patient's real life. We want to make 15 a device the user can truly live in, long term. Because our approach does not involve ECG leads, it will be 16 minimally obtrusive, thereby leading to better acceptance and use by patients. Our wearable device has 17 the potential to disrupt the traditional delivery of AF healthcare. For this objective to be successfully 18 achieved, four key technology pillars must be commercialized. The first is an accurate AF detection 19 algorithm. The second is a reusable, rugged, flexible electrode material that does not cause skin irritation 20 with prolonged use in all real-world conditions. The third is an accurate motion artifact removal 21 algorithm. The fourth is leadless ECG capture. The first two technological developments have been 22 achieved by our company's CTO. Our AF algorithm has been shown to be accurate in multiple peer- 23 reviewed publications, and is now commercially available in a Holter monitor from Scottcare Corporation. 24 We have also developed novel waterproof, flexible, gel-less, reusable electrodes that do not cause skin 25 irritation. Hence, the objective of this SBIR project is to bring to maturity the last two pillar technologies. 26 Preliminary work on concepts for both show great promise. We believe this work will result in rapid 27 translation in later Phases into an innovative and disruptive AF detection product. The envisioned product 28 has the potential to significantly reduce healthcare costs by accurately and more succinctly establishing the 29 diagnosis of AF in at-risk groups, thereby providing clinicians with an opportunity to prevent expensive 30 secondary complications of these life-threatening arrhythmias.