BiVACOR Rotary Total Artificial Heart

总结/摘要 心力衰竭（HF）是一种破坏性疾病，影响全球2000多万患者，其中570万人 美国每年有87万新病例。虽然心脏移植是最好的治疗选择， 在这些患者中，每年全球进行的心脏移植手术不到4200例。此外，目前的增长率 预计到2030年，HF的发病率将增加25%，预计每年的成本为69.7 B美元。美国国家 美国卫生研究院（NIH）估计，10万名患者可以立即受益于机械循环支持 （监控监）。严重心力衰竭患者在不进行干预的情况下前景不佳。药物治疗不是一种有效的 然而，由于供体心脏的可用性有限，目前唯一可行的替代方案是MCS。 心室辅助装置（VAD）和全人工心脏（TAH）是通过外科手术 与严重HF患者的心脏并排植入或替代心脏，以恢复足够的血流。 该领域的技术进步已经解决了与孤立性左心室HF相关的许多问题， 许多左心室辅助装置（LVAD）的商业化。然而，高达30%的HF患者 双心室HF，或LVAD植入后发生。这就需要移除心脏并植入 TAH，或在右心旁植入第二个VAD以提供双心室辅助（BiVAD）。 然而，由于担心，没有充分满足该人群需求的长期双心室器械 关于耐久性和不良事件。BiVACOR器械准备利用这一市场空白。 BiVACOR TAH采用与基于旋转血液的现代成功LVAD相同的方法 泵（RBP）技术与磁悬浮转子，并将其应用于提供同步，可靠， 用于体循环和肺循环的生物相容性支持。该设备已通过概念和 该项目通过私人资金来源进行可行性研究第一阶段，目前正进入开发第二阶段。因此，该SBIR 该提案的目标是直接进入第二阶段的应用，具体目标如下：（1）实施和完善速度 控制算法，以恢复脉动性和流出适应，（2）完善可植入组件的设计， 实现优化的人体解剖学匹配，（3）在设计控制下构建密封器械，以及（4） 体外和长期体内过程验证和器械功能确认。实现这些里程碑 将导致设计冻结，同时证明该产品的临床实用性，提高 技术，从而鼓励进入第三阶段商业化所需的额外投资。 长期实用的机械替代对男性、女性和儿童心脏衰竭的影响 会是巨大的。患者将不再需要等待心脏移植来恢复大大改善的质量 生命将类似VAD技术的成功耐用性和小尺寸用于BiVACOR TAH 提供了一个明确的途径，以实现一个实际的替代失败的人类心脏的目标。

SUMMARY/ABSTRACT Heart Failure (HF) is a devastating disease affecting more than 20 million patients worldwide, with 5.7 million of these American at an incidence of 870,000 new cases each year. Whilst heart transplants provide the best treatment option for many of these patients, less than 4200 heart transplants take place globally each year. Furthermore, current growth rates predict a 25% increase in the incidence of HF by 2030 at an expected cost of USD$69.7 B per annum. The US National Institute of Health (NIH) estimated that 100,000 patients could immediately benefit from mechanical circulatory support (MCS). Patients with severe heart failure have a poor outlook without intervention. Drug therapy is not an effective option, and the limited availability of donor hearts suggests the only viable alternative at this point in time is MCS. Ventricular assist devices (VADs) and Total Artificial Hearts (TAHs) are mechanical pumps that are surgically implanted alongside or in replacement of the heart of patients with severe HF, to restore the adequate blood flow. Technological advances in the field have addressed many issues associated with isolated left ventricular HF resulting in the commercialization of a number of left ventricular assist devices (LVADs). However, up to 30% of HF patients have biventricular HF, or it develops after LVAD implantation. This necessitates the removal of the heart and implantation of a TAH, or the implantation of a second VAD alongside the right heart to provide biventricular assistance (BiVAD). However, there are no long-term biventricular devices that adequately meet the needs of this population due to concerns regarding durability and adverse events. The BiVACOR device is poised to take advantage of this market gap. The BiVACOR TAH utilizes the same approach as the modern successful LVADs which are based on rotary blood pump (RBP) technology with magnetically levitated rotors, and applies it to provide simultaneous, reliable and biocompatible support for both the systemic and pulmonary circulations. The device has progressed though concept and feasibility phase I via private funding sources, and is now entering the development phase II. Therefore, this SBIR proposal is targeting a direct to phase II application, with the following specific aims (1) Implement and refine speed control algorithms to restore pulsatility and outflow adaptation, (2) Refine the design of implantable components while achieving an optimized human anatomical fit, (3) Construct hermetically sealed devices under design controls, and (4) Verification of processes and validation of device function in vitro and chronic in vivo. Attainment of these milestones would lead to a design freeze whilst demonstrating the clinical utility of this product, raising the profile of the technology, and thus encouraging the additional investment needed to enter into Phase III commercialization. The impact of a long-term practical mechanical replacement to the failing human heart for men, women and children would be tremendous. Patients would no longer need to wait for a heart transplant to return to a vastly improved quality of life. Leveraging the successful durability and small size of similar VAD technologies into the BiVACOR TAH provides a clear pathway to achieve the goal of a practical replacement of the failing human heart.