The number of patients suffering from congestive heart failure (CHF) in the U.S. is rapidly increasing, and will soon reach 10 million annually. These patients are typically given multiple drugs and often need frequent dose adjustments that rely upon expensive in-hospital monitoring. As is explained in this proposal, although ambulatory pressure and electrogram monitoring would be ideal for these patients and although direct, left- ventricular (LV) assessment is clearly more beneficial than is indirect right-ventricular monitoring-no method has been developed for accurate, safe, long-term assessment of LV function in ambulatory CHF patients. Phase I will investigate the feasibility of developing a pressure- and electrogram (EGM)-sensing catheter as the enabling component of an implantable, wireless system for long-term monitoring in patients suffering from LV dysfunction and CHF. Data Sciences intends to demonstrate that we can 1) advance our state-of-the-art pressure- measurement technology to meet specifications for human use, 2) fabricate the pressure-transmission catheter (PTO) with materials that are safe and reliable for long-term human use in the left ventricle (LV), and 3) develop a PTC that employs materials proven to be biocompatible and biostable in long-term human use and that will lead to a highly manufacturable design. PROPOSED COMMERCIAL APPLICATIONS: Millions suffer from congestive heart failure (CHF) in the United States and worldwide. The availability of a method to provide long-term hemodynamic outpatient assessment has the potential to optimize patient care, improve quality of life, and reduce costs--significantly advancing the state of the art in CHF management. Developing that capability is the overall goal of this proposed Fast-Track SBIR project. Phase I success will set the stage for the follow-on Phase II R&D, optimization, prototyping and testing needed to pursue FDA approvals and ultimate Phase III commercialization.
