SBIR/STTR Award attributes
ABSTRACT More than 450,000 hospitalizations each year in the US are due to atrial fibrillation (AF) which contributes to approximately 160,000 deaths. This trend has been increasing for more than two decades, with estimations that 12.1 million people in the US will have AF by 2030, placing a significant burden on the healthcare system. Complications of AF include stroke, heart failure, and increasing mortality. AF is a progressive disease with catheter ablation becoming increasingly common for the treatment of AF despite limited and highly variable success rates and complications, with arrhythmia-free survival rates lt 29% at 5 years. The current acute standard of care is external cardioversion, with or without antiarrhythmic drugs. Unfortunately, high-voltage external shocks are extremely painful, can cause additional arrhythmias, and often require escalation of care at an annual cost of ~$26 billion. Efforts to address this unmet need have focused on internal atrial cardioversion which has not been widely adopted due to the invasiveness and intolerable pain suffered from shocks. Efforts to overcome these limitations have focused on wireless implantable devices which have been hindered by high power consumption attributable to power harvesting modules of the circuit design. The Maxwell Biomedical Spatial Resynchronization Therapy (SRT) System resolves the limitations of wireless implantable technologies and high energy cardioversion for treating AF by utilizing spatiotemporal identification and stimulation to globally advance refractoriness of complex reentry patterns enabling imperceptible pace-termination of AF. This is accomplished via the SATELLITETM epicardial implant device, which is a wirelessly powered flexible circuit with multiple paired electrodes that, when implanted, are distributed across the posterior wall of the left atrium. The system records cardiac electrograms from each of the electrodes and the algorithm analyzes these signals to determine electronic selection and pacing of paired electrodes using a state-of-the-art method from Dynamical System Theory. Importantly, it operates below 0.1 J, an order of magnitude below the threshold for pain. Evidence for the effectiveness of this approach has been shown in bench and in vivo studies, where the SATELLITETM silicon CMOS components and sensors demonstrated a power transfer efficiency of 68%, far exceeding current wirelessly powered devices. The ability of the algorithm to identify and pace-terminate AF has also been confirmed in an open chest swine model of AF, which supports the translatability of SRT. The Maxwell Biomedical SRT System is now ready for final refinement of the algorithm and implant hardware to achieve design freeze, which will be characterized first on the bench (Aim 1), followed by the assessment of efficacy and deliverability in vivo (Aim 2). Successful execution of Phase I studies will position SRT System for full development, clinical studies, regulatory approval (future Phase II), and commercialization of a highly disruptive technology to treat the growing population of patients with AF.
