Development of SVAD System for HF Therapy

高频治疗SVAD系统的开发

基本信息

批准号：
8713455
负责人：
Paul A Spence
金额：
$ 32.08万
依托单位：
SCR, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-01 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8713455
关键词：
Acute Adverse event Alloys Anastomosis - action Animal Model Animals Apical Biomedical Engineering Cadaver Caliber Cannulas Cannulations Cardiac Cardiopulmonary Bypass Cardiovascular system Caring Cattle Chronic Clinical Clinical Engineering Clinical Trials Data Development Devices Engineering Fatigue Freezing Goals Healthcare Heart Atrium Heart failure Hospital Costs Human Implant Institutes Intervention Lateral Left Left atrial structure Legal patent Length Medical Modeling Motion Muscle Myocardial Ischemia Obstruction Operative Surgical Procedures Outcome Patients Performance Phase Physicians Physiological Platinum Polyesters Postoperative Period Procedures Pump Quality of life Recovery Research Personnel Resources Risk Safety Shapes Silicones Staging Sternotomy Structure of subclavian artery Suction Surgical sutures System Target Populations Technology Testing Thoracotomy Thrombus Time Translating Weight arm axillary artery biomaterial compatibility commercialization cost design follow-up good laboratory practice implantation improved in vivo industry partner innovation meetings miniaturize nitinol outcome forecast pectoralis major muscle pre-clinical product development prototype public health relevance research clinical testing tool ventricular assist device verification and validation

项目摘要

DESCRIPTION (provided by applicant): The objective of this proposal is to complete the engineering development and pre-clinical testing of the SCR SVAD system to provide partial cardiac assist in patients with less advanced stage heart failure (HF). HF is increasing worldwide and represents a major burden in terms of health care resources and costs. Despite advances in medical care, prognosis with HF remains poor, especially in advanced stages. Currently, it requires a major operative intervention and cardiopulmonary bypass (CPB), which have been associated with significant adverse event rates and long recovery. The high cost of the intervention and patient follow-up has limited widespread acceptance. The SVAD system consists of a miniaturized axial flow pump (platinum alloy impeller and vane diffuser), inflow cannulation to the left atrium, and outflow graft anastomosis to axillary artery. The SVAD pump (6 cm length, 2 cm diameter, 40 g weight) is implanted through a right lateral mini-thoracotomy. The clinical benefits of the SVAD include: eliminates major surgery (sternotomy), LV apical coring, and aortic anastomosis; performed 'off pump' (no CPB); pump placement in subclavicular pocket facilitates implant (and explant) procedure(s); and superior hydrodynamic performance (5 lpm @ 100 mmHg) with low power requirements. In this phase I-II proposal, we will demonstrate feasibility and complete engineering development and pre- clinical testing of the SVAD to support a FDA submission for phase one (n=10) and phase two (n=300) clinical trials. To achieve this objective, we will complete the engineering development and design freeze of the SVAD system with Good Manufacturing Practices (GMP) specifications for a human implant quality system; demonstrate efficacy and biocompatibility by completing Validation and Verification (V&V) testing (fatigue), anatomical fit and surgical procedure study (human cadaver, n=4), and in vivo acute (n=4), chronic 7-day (n=6), and chronic 45-day (n=8) Good Laboratory Practices (GLP) study. The pre-clinical, V&V, GMP, and GLP study data will be used to support an IDE application for a clinical trial in HF patients. Our long-term goal is to clinically translate the SCR SVAD to treat earlier stage HF patients, using miniaturized partial support device, and less invasive surgical tools and procedures to improve patient outcomes and restore quality of life.

描述（由申请人提供）：本提案的目标是完成 SCR SVAD 系统的工程开发和临床前测试，为晚期心力衰竭 (HF) 患者提供部分心脏辅助。心力衰竭在全球范围内不断增加，对医疗保健资源和成本构成了重大负担。尽管医疗保健取得了进步，心力衰竭的预后仍然很差，特别是在晚期。目前，它需要进行重大手术干预和体外循环（CPB），这与显着的不良事件发生率和长期恢复有关。干预和患者随访的高昂成本限制了广泛接受。 SVAD系统由微型轴流泵（铂合金叶轮和叶片扩散器）、左心房的流入插管和腋动脉的流出移植物吻合组成。 SVAD 泵（长 6 厘米，直径 2 厘米，重 40 克）通过右侧小型胸廓切开术植入。 SVAD 的临床益处包括：消除大手术（胸骨切开术）、左心室心尖取芯和主动脉吻合术；进行“停泵”（无体外循环）；将泵放置在锁骨下袋中有助于植入（和外植）手术；卓越的流体动力性能（5 lpm @ 100 mmHg）且功率要求低。在此 I-II 期提案中，我们将展示 SVAD 的可行性以及完整的工程开发和临床前测试，以支持 FDA 提交第一阶段 (n=10) 和第二阶段 (n=300) 临床试验。为了实现这一目标，我们将完成SVAD系统的工程开发和设计冻结，并符合人体植入物质量体系的良好生产规范（GMP）规范；通过完成验证和验证 (V&V) 测试（疲劳）、解剖学拟合和外科手术研究（人体尸体，n=4）以及体内急性（n=4）、慢性 7 天（n=6）来证明功效和生物相容性）和长期 45 天 (n=8) 良好实验室规范 (GLP) 研究。临床前、V&V、GMP 和 GLP 研究数据将用于支持针对 HF 患者进行临床试验的 IDE 应用。我们的长期目标是将 SCR SVAD 临床转化为治疗早期心力衰竭患者，使用小型化部分支持装置以及微创手术工具和程序来改善患者预后并恢复生活质量。