Development of a multi-channel radiofrequency and pulsed field energy source generator for cardiac ablation

Sirona Medical Technologies, Inc., Windsor CT

Investigators

Abstract

ABSTRACT Untreated cardiac arrhythmias can damage the heart, brain, or other organs, and lead to death. Catheter ablation therapy for cardiac arrhythmias is vastly underpenetrated due to its less-than-ideal safety and efficacy profile, procedural complexity, and accessibility. Currently, all ablation catheters are based on the same design principles with similar safety and efficacy outcomes. Sirona’s proprietary technology improves the ablation procedures by blocking the passage of energy to the blood and surrounding structures and delivering the ablation energy in a more precise and predictable manner to the target tissue. Sirona’s Vector Catheter is fully developed and, in both ex-vivo and in-vivo animal studies, achieves the same size ablation lesions as the leading catheter in the market while utilizing substantially less power and irrigation volume. This reduces off-target tissue damage, enables Sirona’s catheter to provide a more accurate measurement of the tissue temperature, thereby delivering energy to the intended target more precisely and safely. Sirona’s Multi-Modal Catheter is multi-electrode catheter designed to address several practical challenges in the ablation space and reduce the procedure complexity, which ultimately will result in increased accessibility of this therapy. This catheter’s unique features include multi- configuration, insulated electrodes, axial rotation, variable array diameter, and lesion overlap control. Both catheters require a customizable, multi-channel, dual energy source generator for selective delivery of ablative energy. The generator must deliver energy in a programmable fashion, of the appropriate magnitude and waveform to the unique arrays of electrodes, switch seamlessly between radiofrequency (RF) and pulsed field (PF) energy sources, and monitor temperature, impedance, and other ablation parameters. These features are not available in commercial generators; therefore, Sirona must develop its own custom generator as an integral part of its ablation system. The goal of this R61 phase is to develop and validate hardware to interface Sirona’s catheters to RF and PF generator platforms and establish signal boundaries and parameters for safe and effective delivery of ablative energy to the target subject. This will be accomplished through: Aim #1: Develop hardware for interfacing Sirona’s catheter(s) with PF and RF generator platforms, Aim #2: Establish signal parameters for safe delivery of the energy, and Aim #3: Establish signal parameters for effective delivery of the energy and dose response data. Accomplishing these milestones allows Sirona to transition to the R33 phase, where Sirona will develop the specifications for optimal hardware and user interface. The R33 phase consists of Specific Aim #4: Develop the hardware allowing the selection of energy source and output channel for delivery of the ablative energy, Aim #5: Develop product requirements for the custom, multi-channel, dual energy source product, Aim #6: Develop first article custom generator and validate the product against the product requirements, Aim #7: Demonstrate safety, efficacy, and efficiency of the custom generator in acute animal studies. Successful completion enables Sirona’s custom generator to be used for future animal and FIH studies.