An Improved Robotic Electrophysiology Platform for Arrhythmia Ablation

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Arrhythmias result from disorganized electrical signals within the heart leading to irregular contractions and are a leading cause of death in the US. Ventricular tachycardia and fibrillation are the most serious arrhythmias resulting in 300k annual US deaths, followed by 130k US deaths due to atrial fibrillation (AF). With a prevalence of 6M in the US, AF is the most common arrhythmia, resulting in 750k annual US hospitalizations. AF-associated medical costs will exceed $50B by 2035. AF therapies first rely on pharmaceuticals to prevent blood clots and to restore rhythm. If these approaches fail, electrophysiology (EP) procedures are performed which pass electrical currents (or coolants) through the catheter’s tip to destroy tissues disrupting proper electrical signals. However, manual catheters rely on complex tension-wire designs operated from a meter away which makes effective catheter control difficult, leading to injury and AF recurrence. Robotic platforms have struggled to improve catheter control for decades. Most robotic systems manipulate standard manual catheters; however, learning curves remain high and catheter tip control is unimproved. Magnet-based systems that use magnetic catheters improve control; however, the systems are impractically large, difficult to use, and require a custom angiography suite. Because all existing robotic solutions remain prohibitively expensive, such systems are found only in a limited number of high-volume centers despite that more than 80% of all hospitals providing ablation are lower-volume centers. What is needed is an affordable and workflow-friendly robotic technology that improves catheter control and enables expertise within high- volume EP centers to be remotely shared with lower-volume centers for training and procedural support. UNandUP’s MAP-EP (Magnetic Assistive Platform for EP) system controls novel linkage-based magnetic catheters using a magnet mass 50X smaller than previously possible. As a result, the MAP-EP system can be installed into existing digital angiography suites without the need for a new c-arm or room construction. Because energy is not expended fighting catheter restoring forces, low magnetic fields achieve stable, accurate, and precise heart wall contact. The technology complements standard EP workflows, is affordable for low-volume EP centers, and provides telerobotic access to expertise within high-volume centers. In the Phase I effort, a prototype magnet workstation was constructed, novel magnetic materials were developed to manufacture smaller and more complex magnets than previously possible, and prototype catheters were successfully built and assessed using known heart phantoms. I-Corps and TABA participation were completed, and FDA pre-submission meetings were held in support of mapping [510(k)], ablation (PMA), and Early Feasibility Studies. For the proposed effort, UNandUP will develop preclinical versions of its system. Efficacy studies will be completed using known beating heart phantoms. Biocompatibility testing and large- animal safety and feasibility studies will be conducted following published methods.