PERMANENT AORTIC BALLOON PUMP

第二阶段SBIR项目的目标是鉴定 永久性主动脉球囊反搏在难治性左心室的临床试验 心室衰竭（LVF）。 该系统提供了一个独特的 平衡获益和低风险，因此在第三阶段， 在慢性充血性左心室纤维化的治疗中赢得一席之地。 的 永久性主动脉球囊系统支持左心室， 治疗有效水平，同时最大限度地提高患者安全性。 它在左心室辅助系统中的独特之处在于， 连续的泵送动作不是强制性的。 这个病人能 几个小时都没被拴着 在第一阶段，重新设计的血泵 在5头间歇泵送的小牛中成功测试， 6周内的抗凝治疗。 这些结果导致 第二阶段，我们的具体目标是： 1. 为了确认和定量血液动力学效应， 急性心力衰竭小牛的永久性主动脉球囊 已经被诱导了。 2. 表征系统的性能极限。 3. 证明2年内的体外组件可靠性 设计寿命 4. 测试并记录系统的可靠性和安全性 在8只动物长期（6个月）试验中。 5. 制定研究计划、方案和知情同意书 这将保证医院IRB和FDA批准试验 在人类实验对象中。

The objective of this Phase II SBIR project is to qualify the permanent aortic balloon pump for clinical trial in intractable left ventricular failure (LVF). The system provides a distinctive balance of benefits and low risk so that in Phase III, it is expected to earn a niche among therapies for chronic congestive LVF. The permanent aortic balloon system supports the left ventricle at therapeutically effective levels while maximizing patient safety. It is unique among left ventricular assist systems in that its continuous pumping action is nonobligatory. The patient can be untethered for hours. During Phase I, the redesigned blood pump was successfully tested in 5 calves pumped intermittently without anticoagulant therapy over a 6 week period. These results lead to Phase II in which our specific aims are: 1. To confirm and quantitate hemodynamic effects of the permanent aortic balloon in calves in which acute heart failure has been induced. 2. To characterize the performance limits of the system. 3. To demonstrate in vitro component reliability over a 2-year design life. 4. To test and document the reliability and safety of the system in long-term (6 month) test in each of 8 animals. 5. To develop an investigational plan, protocols and consent form that will warrant approval by the hospital IRB and FDA for trial in human subjects.