PERMANENT AORTIC BALLOON PUMP

永久性主动脉球囊泵

• 批准号: 3508430
• 负责人: ADRIAN KANTROWITZ
• 金额: $ 36.85万
• 依托单位: VIADERM, LLC
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-21 至 1989-09-20
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3508430
• 关键词: aortic balloon pump; auxiliary heart prosthesis; biomedical equipment resource; biomedical equipment safety; clinical biomedical equipment; heart failure; hemodynamics

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.

第二阶段SBIR项目的目标是使