Development of SVAD System for HF Therapy

高频治疗SVAD系统的开发

• 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
• 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

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）：本提案旨在完成SCR SVAD系统的工程开发和临床前测试，为不太晚期心力衰竭（HF）患者提供部分心脏辅助。HF在全球范围内不断增加，在医疗资源和成本方面构成了主要负担。尽管医疗保健的进步，HF的预后仍然很差，特别是在晚期。目前，它需要大手术干预和心肺转流（CPB），这与显著的不良事件发生率和长期恢复有关。干预和患者随访的高成本限制了广泛接受。SVAD系统由小型轴流泵（铂合金叶轮和叶片扩散器）、左心房流入插管和腋动脉流出移植物吻合组成。SVAD泵（6 cm长，2 cm直径，40 g重量）通过右侧小切口植入。SVAD的临床受益包括：消除了大手术（胸骨切开术）、LV心尖取芯和主动脉吻合术;进行了“非体外循环”（无CPB）;将泵放置在锁骨下囊袋中有助于植入（和取出）手术;以及上级流体动力学性能（5 lpm@100 mmHg）和低功率要求。在本I-II期提案中，我们将证明SVAD的可行性并完成SVAD的工程开发和临床前测试，以支持FDA提交的I期（n=10）和II期（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;通过完成确认和验证（V&V）测试（疲劳）、解剖结构匹配和手术研究证明有效性和生物相容性（人尸体，n=4）和体内急性（n=4）、慢性7天（n=6）和慢性45天（n=8）药物非临床研究质量管理规范（GLP）研究。临床前、V&V、GMP和GLP研究数据将用于支持HF患者临床试验的IDE申请。我们的长期目标是 在临床上将SCR SVAD转化为治疗早期HF患者，使用小型化部分支持器械以及微创手术工具和手术，以改善患者结局并恢复生活质量。