This Small Business Innovation Research Phase II project proposes to develop a novel ablation balloon catheter to perform radiofrequency ablation on atrial fibrillation patients. The intellectual merit of this project is in its use of an innovative approach to positioning, mapping, and ablation for atrial fibrillation patients, negating the need for excessive catheter rotations and/or serial point ablations. This new technology significantly reduces user variability, procedural time, and the resultant cost burden on the hospital, physician, insurance payer, and patient. The research objectives for this project are to design and develop an improved prototype that enables verification of balloon-to-tissue contact; design and develop a 2nd generation radiofrequency generator capable of powering 20 electrodes; refine catheter design to increase reliability/robustness and sheathing capability; and develop 2nd generation handle that allows for the balloon extension. All of these changes will be validated through in vitro and in vivo testing.
The broader impact/commercial potential of this project is an improvement in the treatment of atrial fibrillation, which is the most common heart rhythm disturbance encountered in clinical medicine, accounting for 1/3 of hospital admissions for cardiac rhythm disturbances. It is estimated that nearly 2.6 million individuals are currently afflicted with atrial fibrillation in the United States, with a projected increase to nearly 4.4 million people by the year 2030. Given the significant public health and economic impact of atrial fibrillation, there is an urgent need for practical and cost-effective approaches to treat atrial fibrillation. This technology aims to answer this need, providing an improved method of treatment for patients as well as highly-marketable technology that will save hospitals time and costs burdens.