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.
". The goal of this grant was to further the development of a novel, balloon-based radio frequency (RF) ablation device that more effectively treats atrial fibrillation. Atrial fibrillation is an abnormal heart rhythm, and is the most common heart rhythm disturbance encountered in clinical medicine, accounting for 1/3 of hospital admissions for cardiac rhythm disturbances. 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. Currently, ablation of certain areas of the heart via an electrode catheter is the standard of care for treating patients with paroxysmal atrial fibrillation. With commercially available electrode catheters, ablation can require doctors to do extensive and time-consuming (typically 3-4 hours) manipulation of the device to get its placement correct and to create the desired pattern of ablation. Successful procedures thus require highly skilled physicians. Furthermore, efficient and complete mapping of the electrical activity in target tissues often requires the placement of multiple catheters, the use of a 3D-mapping, and/or a steering system. Apama’s device uses multiple flexible electrodes (as opposed to stiff electrodes used in existing devices) on the exterior of the balloon, which enables superior placement of the device on the correct areas of the heart and requires less manipulation of the device. Further, the prototype device allows the user to selectively control each individual electrode – enabling the creation of highly flexible patterns of ablation around the heart with much less manipulation. This will greatly reduce procedure times and reduce the necessary skill level required to achieve successful results. Expanding the number of physicians performing the procedure will allow many more medical centers, and thus many more patients, access to this curative strategy. During our Phase I project, we demonstrated the usability and potential benefit of a novel balloon-based RF ablation catheter. The end result was a working prototype and proof that it worked in animal studies. Specifically, we demonstrated: • The ability to select specific electrodes to form a single shot circumferential ablation pattern of desirable depth and size based on specific inputs (temperature, time, power) • The device was shown to be easy to use and was able to map and display signals from the heart through mapping and ablation electrodes in a series of animal studies. • Through bench testing, the device was shown to work as it was intended reliably at this early stage. • The RF Generator tested worked well with the catheter to safely deliver the energy required to obtain the appropriate ablations for good clinical outcome. • The catheter device is not toxic to animals and is sterilizable
