SBIR Phase I: Pre-clinical Development of Device to Guide Heart Recovery via Assist and Support

这个小企业创新研究（SBIR）第一阶段项目的重点是一种治疗心力衰竭的新型疗法，该疗法采用设备介导的干预来指导心脏生长、重塑和恢复。CorInnova设备是第一个将联合收割机主动心脏辅助和被动心脏支持相结合的设备。它不接触血液，植入后可调节，可通过微创外科手术输送。因此，CorInnova的技术代表了现有心脏辅助和现有心脏支持技术的重大进步。虽然该装置在有限的短期动物研究中显示出潜力，但其设计的全部能力和局限性尚不清楚。这项研究计划旨在确定这些能力和局限性。这项研究的更广泛的影响在充血性心力衰竭（CHF）的治疗中是重要的。CHF是一种使人衰弱的疾病，目前困扰着近500万美国人。据估计，每年的处理费用超过500亿美元。对于30万患有“终末期心力衰竭”的美国人来说，移植是首选的治疗方案。然而，缺乏供体心脏使得这种治疗选择“在流行病学上微不足道”。对于大多数这些患者，心脏康复的潜力被忽视。因此，所提出的技术代表了治疗范式的转变-一种旨在刺激恢复性生长和重塑过程的干预-基本上为心肌提供康复物理治疗。该设备的多功能性使心脏病专家能够通过调整被动支持组件和应用主动心脏辅助来提供战术干预手段。该奖项是根据2009年美国复苏和再投资法案（公法111-5）资助的。

This Small Business Innovation Research (SBIR) Phase I project is focused on a novel therapy for heart failure that employs device mediated intervention to guide cardiac growth, remodeling, and recovery. The CorInnova device is the first to combine active cardiac assist and passive cardiac support. It is non-blood contacting, adjustable post-implantation, and can be delivered via minimally invasive surgical procedures. Hence, CorInnova's technology represents a substantial advancement from both, existing cardiac assist and existing cardiac support technologies. While the device has shown potential in limited short-term animal studies, the full capabilities and limitations of the design are as yet unknown. The research plan is aimed at determining these capabilities and limitations.The broader impacts of this research are important in the treatment of Congestive Heart Failure (CHF). CHF is a debilitating condition that currently afflicts nearly 5 million Americans. Treatment costs are estimated to be in excess of $50 billion per year. For the 300,000 Americans in "end-stage heart failure", transplant is the preferred treatment option. However, the lack of donor hearts renders this treatment option "epidemiologically trivial". For most of these patients, the potential for cardiac rehabilitation is neglected. Thus, the proposed technology represents a shift in the treatment paradigm - an intervention conceived to stimulate restorative growth and remodeling processes - essentially providing rehabilitative physical therapy for the heart muscle. The versatility of the device empowers the cardiologist, providing the means for tactical intervention via adjustments to the passive support component and application of active cardiac assist.This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).