Implantable Pressure/Electrogram Sensor for CHF

在美国，患有充血性心力衰竭（CHF）的患者数量正在迅速增加，并且很快将达到每年1000万。这些患者通常被给予多种药物，并且经常需要频繁的剂量调整，这依赖于昂贵的住院监测。如本提案所述，尽管动态血压和电描记图监测对这些患者是理想的，尽管直接左心室（LV）评估明显比间接右心室监测更有益，但尚未开发出准确、安全、长期评估动态CHF患者LV功能的方法。第一阶段将研究开发一种压力和电描记图（EGM）传感导管作为植入式无线系统的使能组件的可行性，用于对患有LV功能障碍和CHF的患者进行长期监测。Data Sciences旨在证明，我们可以1）推进我们最先进的压力测量技术，以满足人类使用的质量标准，2）使用安全可靠的材料制造压力传输导管（PTO），供人类在左心室（LV）中长期使用，以及3）开发一种PTC，其采用在人类长期使用中被证明是生物相容性和生物稳定性的材料，并且将导致高度可制造的设计。拟议的商业应用：在美国和世界各地，数百万人患有充血性心力衰竭（CHF）。提供长期血流动力学门诊评估的方法的可用性具有优化患者护理、提高生活质量和降低成本的潜力-显著推进CHF管理的最新技术水平。开发这种能力是这个拟议的快速通道SBIR项目的总体目标。第一阶段的成功将为后续的第二阶段研发、优化、原型设计和测试奠定基础，这些都是追求FDA批准和最终的第三阶段商业化所需的。

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.