Development of a percutaneously implantable, ambulatory, long-term intravascular ventricular assist system

开发经皮植入、流动、长期血管内心室辅助系统

• 批准号: 10258104
• 负责人: Sonna Patel-Raman
• 金额: $ 25.66万
• 依托单位: NUPULSECV, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10258104
• 关键词: Acute; Adult; Adverse event; Air; Animals; Blood Vessels; Caliber; Cardiac; Cardiac Output; Cardiac Surgery procedures; Caring; Catheters; Chronic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Complex; Counterpulsation; Descending aorta; Development; Devices; EFRAC; Electrocardiogram; Engineering; FDA approved; Freezing; Generations; Heart failure; Hemostatic Agents; Hemostatic function; Home; Hour; Image; Implant; Implantation procedure; International; Intra-Aortic Balloon Pumping; Ischemia; Israel; Laboratories; Lead; Mechanics; Medical; Medical center; Operative Surgical Procedures; Patients; Phase; Physicians; Population; Procedures; Pump; Quality of life; Resistance; Safety; Secure; Site; Skin; Small Business Innovation Research Grant; Support System; Surface; Surgeon; System; Technology; Testing; Therapeutic; Treatment Cost; Ventricular; Work; Workload; axillary artery; cardiac resynchronization therapy; coronary perfusion; cost; design; femoral artery; hemodynamics; implantable device; implantation; indexing; innovation; left ventricular assist device; minimally invasive; mortality; patient mobility; phase 1 study; pre-clinical; product development; programs; sheep model; subcutaneous; tool; verification and validation

ABSTRACT Heart failure (HF) rapidly progresses despite optimal medical management and cardiac resynchronization therapy. Left ventricular assist devices are reserved only for end-stage HF due to surgical invasiveness. Long- term mechanical circulatory support options for less sick heart failure patients (Class III, early Class IV), which may slow down or reverse HF progression, are limited. To fulfill this therapeutic gap, NuPulseCV (Raleigh, NC) is developing a percutaneously delivered, chronic implantable, second-generation counterpulsation system (iVAS) to treat HF patients. The NuPulseCV iVAS has been developed for less invasive percutaneous implantation in the descending aorta in a cardiac catheter laboratory by a cardiologist within 1.5 hours, and enables complete patient mobility. In an ongoing FDA approved clinical study, the first-generation iVAS was successfully implanted in over 80 patients using a surgical approach and demonstrated statistically significant hemodynamic improvements in cardiac index (39%), ejection fraction (48%), and cardiac power index (35%) over baseline values. However, the first-generation iVAS used for the clinical studies requires a cardiac surgeon and two assistants to implant the device, takes ~4 hours to implant, and requires a surgical suite. In this SBIR Phase I study, we will demonstrate feasibility of a percutaneously delivered second-generation iVAS to provide chronic counterpulsation support. This objective will be accomplished by (1) fabrication of the second generation iVAS and implant tools designed for percutaneous delivery, (2) demonstrating feasibility using acute and chronic ovine models. Results from the SBIR Phase I study will be used for optimization of the percutaneous iVAS during SBIR Phase II, which will then lead to an FDA submission for a pivotal study. The program detailed in this proposal leverages the engineering expertise and development work of NuPulseCV guided by an innovative group of physicians at Beth Israel Deaconess Medical Center (BIDMC). Our long-term objective is to successfully introduce the second generation iVAS system into the clinical setting as a long-term counterpulsation therapy to treat heart failure patients with minimal adverse events and help restore their quality of life.

摘要 尽管进行了最佳的医疗管理和心脏起搏，心力衰竭（HF）仍会迅速进展 疗法由于手术侵入性，左心室辅助装置仅保留用于终末期HF。长- 对于病情较轻的心力衰竭患者（III级，早期IV级）， 可能减缓或逆转HF进展，是有限的。为了填补这一治疗空白，NuPulseCV（罗利，NC） 正在开发一种持续输送的慢性植入式第二代反搏系统 （iVAS）来治疗HF患者。NuPulseCV iVAS已开发用于微创经皮 由心脏病专家在1.5小时内在心脏导管实验室植入降主动脉，以及 使患者能够完全移动。在一项正在进行的FDA批准的临床研究中， 使用手术入路在80多名患者中成功植入，并证明具有统计学意义 心脏指数（39%）、射血分数（48%）和心脏功率指数（35%）的血流动力学改善 超过基线值。然而，用于临床研究的第一代iVAS需要心脏 外科医生和两名助手植入器械，植入时间约为4小时，需要手术室。在 在SBIR第一阶段研究中，我们将证明持续输送第二代iVAS的可行性 以提供慢性反搏支持。 这一目标将通过（1）制造第二代iVAS和植入工具来实现 设计用于经皮递送，（2）使用急性和慢性绵羊模型证明可行性。 SBIR I期研究的结果将用于SBIR期间经皮iVAS的优化 第二阶段，然后将导致FDA提交一项关键研究。 本建议书中详细介绍的计划利用了工程专业知识和开发工作， NuPulseCV由Beth Israel Deaconess Medical Center（BIDMC）的一组创新医生指导。 我们的长期目标是将第二代iVAS系统成功引入临床环境 作为一种长期的反搏疗法，治疗心力衰竭患者，不良事件最少， 恢复他们的生活质量