PercAssist LVAD Technology for healthy independent living for heart disorder.

PercAssist LVAD 技术可帮助心脏病患者健康独立生活。

• 批准号: 10188361
• 负责人: Albert K Chin
• 金额: $ 22.1万
• 依托单位: PERCASSIST, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2022-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10188361
• 关键词: Acute; Address; Adult; Affect; Animal Model; Animals; Aorta; Cardiac; Cardiac Output; Cardiac Surgery procedures; Cardiovascular system; Catheters; Cause of Death; Centers for Disease Control and Prevention (U.S.); Chest; Chronic; Clinical; Clinical Research; Data; Development Plans; Device Approval; Devices; Dyspnea; Elderly; Evaluation; Failure; Fatigue; Funding; Future; Goals; Heart; Heart Diseases; Heart Massage; Heart Rate; Heart Transplantation; Heart failure; Home; Implant; Independent Living; Individual; Infection; Location; Measures; Mechanics; Medical; Morbidity - disease rate; Needles; Operative Surgical Procedures; Outcome; Outpatients; Palliative Care; Patients; Performance; Pericardial body location; Pharmacology; Phase; Physiologic pulse; Positioning Attribute; Postoperative Period; Puncture procedure; Refractory; Reporting; Research; Rest; Safety; Signal Transduction; Sternotomy; Stroke; Systole; Technology; Testing; Thoracotomy; Thromboembolism; Thrombosis; Transplantation; United States; United States Food and Drug Administration; Ventricular; base; cardiac implant; commercialization; cost; design; experience; first-in-human; implantable device; implantation; left ventricular assist device; meetings; minimally invasive; pericardial sac; porcine model; portability; pre-clinical; procedure cost; prototype; sensor; success; ventricular assist device; verification and validation

PercAssist is developing a percutaneous ventricular assist device (VAD) implanted in an extra-cardiac position for chronic ventricular support. Heart disease remains the leading cause of death according to the Center for Disease Control and Prevention (CDC) and heart failure affects 5.7 million adults in the United States. For end stage heart failure (ESHF), the limited availability of donor hearts for transplantation leaves VADs as the only option for patient survival. However, current VAD implantation is severely limited, due to high device and procedural costs, invasiveness of open chest placement, and complications of thromboembolism, stroke and infection. The goal of this Phase 1 proposal is to show efficacy of a VAD that is placed in a minimally invasive extracardiac fashion and complete fatigue testing of the implant. The specific aims of this proposal are to: (Specific Aim 1) Design and prototype an implantable balloon and catheter that will pass the fatigue and durability testing required for a first in man (FIM) study. The milestone for SA1 is that the Balloon Implant reaches a minimum of 40 million cycles without durability failures. Cardiovascular implants may require 200 million cycles63 prior to device approval, we aim for 40 million cycles with the Phase 1 application as patients are typically on VADs for 2-6 months as bridge to transplants.65 40 million cycles is roughly a year’s worth of durability data at an average heart rate of 70 BPM. Based on experience with prior cardiac implants we believe this will be a sufficient starting point for initiating conversations with the FDA for a FIM trial. (Specific Aim 2) Percutaneously deliver and anchor the Percassist implant in a porcine model and demonstrate substantial continued cardiac output (CO) increase relative to a DCM (direct cardiac massage) baseline. The pre-clinical cadence is defined as follows: 1) Surgically implant balloon into pericardium and synchronize with beating heart. Demonstrate a percentage increase in CO quantitatively measured using an aortic flow probe at the aorta with implant (complete). 2) Identify and sustain CO increase (CO will be quantitatively measured with the device and using DCM) over a min. This ratio will be the quantitative marker for success in Milestones 3 and 5. 3) Sustain CO increase (identified above) with anchoring catheter. Success is defined as meeting the CO identified in Milestone 2 for a minute. 4) Deliver balloon percutaneously and synchronize with beating heart. Success is defined as reaching the pericardial space and delivering the device without surgical intervention. 5) Anchor balloon percutaneously and sustain CO increase (identified above in Milestone 2) over a min. Milestones 1 ,2 and 3 will be supported by outside funding. Milestones 4 and 5 will be directly reported on as part of this application. A future Phase 2/2b will support Verification, Validation and Market release as demonstrated in the development plan below. A more detailed Commercial Plan will be included in a future Phase 2 proposal.

PercAsset正在开发一种经皮心脏辅助装置(VAD)，植入心脏外位置治疗 慢性脑室支持。根据疾病控制中心的数据，心脏病仍然是主要的死亡原因 美国有570万成年人受到疾病预防(CDC)和心力衰竭的影响。对于终末期心力衰竭(ESHF)， 供体心脏移植的可获得性有限，使VADS成为患者生存的唯一选择。然而， 目前的VAD植入术受到严重限制，原因是设备和程序成本高，开胸置入具有侵袭性， 以及血栓栓塞症、中风和感染的并发症。此阶段1提案的目标是展示 VAD以微创的心外方式放置，并对植入物进行完整的疲劳测试。具体的 这项建议的目的是： (具体目标1)设计并制作可植入球囊和导管的原型，以通过疲劳和耐久性测试 第一个人(FIM)研究所需的。SA1的里程碑是气球植入物至少达到4000万 无耐用性故障的循环。心血管植入可能需要2亿个周期63才能获得设备批准，我们 目标是通过第一阶段应用实现4000万个周期，因为患者通常需要服用2-6个月的VADS作为桥梁 移植。在平均心率为70 BPM的情况下，4000万个周期大约相当于一年的耐久性数据。基于 以前的心脏植入经验我们相信这将是一个足够的起点，开始与 FDA要求进行FIM试验。 (特定目标2)在猪模型中经皮传递和固定PercAssiste植入物，并证明 相对于DCM(直接心脏按摩)基线，心输出量(CO)持续增加。临床前的节奏是 定义如下：1)外科手术将气囊植入心包，并与心脏跳动同步。演示 使用主动脉血流探头在有植入物的主动脉定量测量CO增加的百分比(完全)。2) 确定并维持一分钟内的CO增加(CO将使用设备和DCM进行定量测量)。这 比率将成为里程碑3和5的成功的量化标志。3)持续增加一氧化碳(如上所示) 锚定导管。成功的定义是在一分钟内满足里程碑2中确定的CO。4)投放气球 经皮并与跳动的心脏同步。成功的定义是到达心包间隙并提供 不需要手术干预的装置。5)经皮锚定气球并维持CO增加(以上在 里程碑2)超过一分钟。里程碑1、2和3将得到外部资金的支持。里程碑4和5将直接 作为本申请的一部分进行了报道。 未来的阶段2/2b将支持开发计划中展示的验证、确认和市场发布 下面。更详细的商业计划将包括在未来的第二阶段提案中。