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

SBIR 第一阶段：通过协助和支持指导心脏康复的设备的临床前开发

• 批准号: 0912711
• 负责人: Michael Moreno
• 金额: $ 10万
• 依托单位: CORINNOVA INC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2009-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0912711&HistoricalAwards=false
• 关键词: SBIR; Phase; Pre; clinical; Development

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).

这个小型企业创新研究(SBIR)第一阶段项目的重点是一种治疗心力衰竭的新疗法，该疗法使用设备中介干预来指导心脏生长、重塑和恢复。CorInnova设备是第一个将主动心脏辅助和被动心脏支持结合在一起的设备。它是非血液接触性的，植入后可调节，并可通过微创手术程序提供。因此，CorInnova的技术代表着现有心脏辅助和现有心脏支持技术的重大进步。虽然该设备在有限的短期动物研究中显示出了潜力，但该设计的全部功能和局限性尚不清楚。该研究计划旨在确定这些能力和限制。这项研究的更广泛影响在充血性心力衰竭(CHF)的治疗中非常重要。慢性心力衰竭是一种令人衰弱的疾病，目前正困扰着近500万美国人。据估计，治疗费用每年超过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，由于缺乏供者心脏，这种治疗方案在流行病学上显得微不足道。对于这些患者中的大多数，心脏康复的潜力被忽视了。因此，这项拟议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--本质上是为心肌提供康复物理治疗。该设备的多功能性为心脏病专家提供了通过调整被动支持组件和应用主动心脏辅助进行战术干预的手段。该奖项由2009年《美国复苏和再投资法案》(Public Law 111-5)资助。