SBIR Phase I:An innovative ablation device for treating atrial fibrillation

This Small Business Innovative Research (SBIR) Phase I Project will develop a novel balloon-based radio freqyency (RF) ablation catheter for atrial fibrillation treatment. Atrial fibrillation is the most common heart rhythm disturbance encountered in clinical medicine, accounting for 1/3 of hospital admissions for cardiac rhythm disturbances. Atrial fibrillation is frequently treated with catheter-based ablation; however, established RF methods are done via point to point manipulation using single electrode tip catheters. As a result, this technique is complex and time-consuming, requiring highly skilled physicians. Newer approaches include multi-electrode RF catheters, which have shown to create undesirable clot formations. Furthermore, mapping of the electrical activity in target tissues often requires the placement of multiple catheters in the left atrium, use of a 3D-mapping, and/or steering system. Current technologies have failed to overcome these limitations or have limited efficacy and/or safety. This project will develop a novel device that avoids these problems with an ablation balloon catheter that combines the conformability advantage of balloon-based approaches with simplicity and versatility of multi-electrode approaches. The device's utility will be validated in animal trials. This broader/commercial impact of this project, if successful, will be to generate a novel device that enables a safer, simpler and faster treatment for atrial fibrillation. This will allow a larger number of physicians to perform this procedure. The ease of use combined with lower cost (no need for expensive robotic and mapping systems) will fit well with the requirements of smaller hospitals that currently refer their patients to larger centers, as well as the more cost-efficient larger hospitals. This would be a major benefit to the 2.6 million atrial fibrillation patients in the U.S. alone that may be treated with catheter-based ablation. Atrial fibrillation is directly related to significant morbidity including debilitating palpitations, heart failure, recurrent hospitalizations, and stroke. An improved method of treating this condition will help mitigate these problems and treat a larger population of patients than possible with current methods and technology. As this device is a significant improvement over existing devices it is well-positioned to capture a large portion of the catheter ablation market.