The first clinical use of the BiVACOR Total Artificial Heart

BiVACOR 全人工心脏首次临床应用

• 批准号: 10698258
• 负责人: Daniel Timms
• 金额: $ 156.95万
• 依托单位: BIVACOR, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698258
• 关键词: Adult; Affect; Anatomy; Blood; Blood flow; Cardiovascular Diseases; Case Study; Cause of Death; Cessation of life; Child; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Development; Devices; Documentation; Epidemic; FDA approved; Failure; Feasibility Studies; Friends; Future; Goals; Grant; Health; Health Care Costs; Healthcare Systems; Heart; Heart Transplantation; Heart failure; Hospitals; Human; Institutional Review Boards; Investments; Left; Magnetism; Mechanics; Medical; Membrane; Organ Donor; Outcome; Pathway interactions; Patients; Performance; Phase; Physiological; Procedures; Pump; Quality of life; Safety; Scheme; Small Business Innovation Research Grant; Study Subject; System; Systems Integration; Technology; Time; Transplantation; United States; Update; Ventricular; Woman; biomaterial compatibility; blood pump; commercial application; commercialization; cost; course development; data submission; effective therapy; first-in-human; implantation; improved; in vivo; innovation; left ventricular assist device; manufacture; manufacturing process; mechanical circulatory support; men; product development; programs; safety and feasibility; success; total artificial heart; transplantation therapy; ventricular assist device

SUMMARY/ABSTRACT Heart Failure (HF) is a devastating epidemic affecting more than 23 million patients worldwide; in the U.S. alone, 1,000,000 new cases are reported each year. While heart transplantation provides the best treatment option for many patients, less than 6,000 procedures take place globally each year. Consequently, it is estimated that 50,000 – 100,000 patients could immediately benefit from mechanical circulatory support. Many circulatory support devices are available for patients who require left ventricular support, but few options exist for patients who would benefit from biventricular support. With the exception of transplantation, the optimal approach to biventricular failure is the replacement of the native heart with a Total Artificial Heart (TAH). Traditional approaches have used volume displacement pumps, which have inherent limitations due to their large size, flexing membranes, and valves that conspire to reduce the durability and lifetime of the device. The same limitations were observed throughout the early application of VAD technology, which prompted a transition to rotary blood pumps for size reduction and increased durability. Today, more than 60,000 patients are supported with rotary VADs. Capitalizing on the advantages of rotary blood pump technology, the BiVACOR TAH is small, reliable, blood-friendly and has inherently balanced blood flows. Under the previous SBIR grants, the system components of the BiVACOR TAH were significantly improved and validated on the benchtop and in-vivo. BiVACOR has entered the final product development and manufacturing phase and wishes to utilize the SBIR II scheme to use the BiVACOR TAH system for the first time clinically via an FDA-approved Early Feasibility Study (EFS). To achieve this goal, the following specific aims will be completed: 1) clinical study initiation; 2) evaluate the safety and performance of the BIVACOR TAH in a clinical study; and 3) evaluate the outcomes of the Early Feasibility Study and identify required device updates. The commercial application and viability of this product will be demonstrated and will encourage additional investment for full commercialization. The world-wide impact of a commercially viable, long-term mechanical replacement to the failing human heart will be tremendous. The wait for patients desperately requiring a heart transplant will go from years to off-the- shelf availability, thereby quickly providing a vastly improved quality of life. Leveraging the successful durability and small size of similar technologies used for ventricular assistance into the BiVACOR rotary TAH provides a promising pathway to finally achieve the goal of a reliable, biocompatible, physiological, and ultimately practical replacement to the failing human heart.

摘要/摘要 心力衰竭（HF）是一种毁灭性的流行病，影响了全球超过2300万患者。仅在美国， 每年有1,000,000例新病例。心脏移植提供了最好的治疗选择 许多患者每年在全球范围内进行少于6,000个程序。因此，据估计 50,000 - 100,000名患者可以立即受益于机械电路支持。 许多电路支撑设备可用于需要左心室支撑的患者，但很少选择 适用于将受益于双脑室支持的患者。除移植外，最佳 室室衰竭的方法是用完全人造心脏（TAH）替换天然心脏。 传统方法使用了体积位移泵，它们由于其而具有继承的局限性 大尺寸，弯曲的机制和阀门降低设备的耐用性和寿命。 在整个VAD技术的早期应用中，都观察到相同的限制，这促使过渡 旋转血泵以减小尺寸和增加的耐用性。如今，超过60,000名患者 由旋转vad支撑。利用旋转血泵技术的优势，双子座 塔（Tah）很小，可靠，对血液友好，具有天生的平衡血液流动。 在先前的SBIR补助下，双虎TAH的系统组件得到了显着改善，并且 在台式和体内验证。 Bivacor进入了最终产品开发和制造业 阶段并希望利用SBIR II方案在临床上首次使用Bivacor TAH系统。 FDA批准的早期可行性研究（EFS）。为了实现这一目标，以下具体目标将是 完成：1）临床研究计划； 2）评估临床中双歧杆菌TAH的安全性和性能 学习; 3）评估早期可行性研究的结果并确定所需的设备更新。这 将展示该产品的商业应用和可行性，并鼓励额外的投资 全面商业化。 商业上可行的长期机械替代人的全球影响力对失败的人心的影响 将是巨大的。等待迫切需要心脏移植的患者将从几年到现年 货架可用性，从而迅速提供了大大改善的生活质量。利用成功的耐用性 以及用于双室旋转tah的少量类似技术，可提供 最终实现可靠，生物相容性，物理和最终实用的目标的有希望的途径 取代人类心脏。