Pediatric Cardiovascular Device Consortium

儿科心血管设备联盟

• 批准号: 7936908
• 负责人: Pedro J. del Nido
• 金额: $ 50.01万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7936908
• 关键词: Pediatric; Cardiovascular; Device; Consortium

DESCRIPTION (provided by applicant): Pediatric device development and evaluation has been recognized as a critical need to improve the lives and welfare of children with congenital and acquired illnesses. The numerous challenges faced by device developers and manufacturers have resulted in a large unmet need for pediatric devices and in particular, cardiovascular devices. The aim of the Pediatric Cardiovascular Device Consortium (PCDC) is to provide expertise and resources to device developers and manufacturers at each of the steps necessary for novel pediatric cardiac device development, in order to accelerate the pace of innovation. The PCDC is a collaborative of experts in engineering, cardiac clinical sciences, clinical trials design and performance, device development specialists, and industry partners whose goal is to develop and evaluate novel therapies for children with cardiovascular defects. The Consortium is a Partnership between a National Institutes of Health (NIH) sponsored trial group (Pediatric Heart Network (PHN)), Data Coordinating Center (NERI), engineering expertise specifically in pediatric devices (Georgia Institute of Technology, GIT) and regulatory and commercialization expertise (NERI, GIT, and Children's Hospital technology development office (TIDO)). The PHN is a working group of 8 core and 13 satellite pediatric clinical centers that have a track record of successfully collaborating in PHN sponsored clinical trials. The application proposes that four projects be supported in the initial phase: 1. Bioabsorbable Valve Annuloplasty Ring for Children (Bioring); 2. Pediatric Ultrasound Imaging Development (Philips); 3. Pediatric Circulatory Assist Device clinical evaluation (Levitronix); and 4. Congenital Heart Valve Cinching Project (GIT). These projects range from early prototype development and preclinical evaluation to safety and probable clinical efficacy trials. Thus, they cover the range of pediatric device development. The Consortium also proposes to develop clinical tools for assessing neurodevelopmental and quality of life outcomes in children, which can be used as a model for future pediatric device trials. The strengths of the PCDC are the pediatric clinical and multicenter trials expertise, engineering knowledge in pediatric devices, and regulatory expertise and commercialization track record specifically for medical devices for children.

描述（由申请人提供）： 小儿装置的开发和评估被认为是改善先天和熟食儿童的生活和福利的迫切需要。设备开发人员和制造商面临的众多挑战导致对儿科设备，尤其是心血管设备的未满足需求。小儿心血管装置财团（PCDC）的目的是为设备开发人员和制造商提供专业知识和资源，以加速创新的新小儿心脏设备开发所需的每个步骤。 PCDC是工程专家，心脏临床科学，临床试验设计和性能，设备开发专家以及行业合作伙伴的专家合作，其目标是为患有心血管缺陷的儿童开发和评估新颖的疗法。该联盟是国家卫生研究院（NIH）赞助的试验小组（儿科心脏网络（PHN）），数据协调中心（NERI），专门针对儿科设备（GEORGIA技术，GIT）和法规和商业化专业知识（NERI和商业化的工程专业知识）（NERI）（NERI，GIT，GIT，HOSIDELD TEVELLECT（TIC）的工程专业知识（TIC）， PHN是一个由8个核心和13个卫星小儿临床中心组成的工作组，在PHN赞助的临床试验中成功合作的记录记录。该申请提出在初始阶段支持四个项目：1。儿童生物吸附阀环形成形术环（Bioring）； 2。小儿超声成像开发（飞利浦）； 3。小儿循环辅助装置临床评估（Levitronix）；和4。先天性心脏瓣膜收缩项目（GIT）。这些项目范围从早期原型开发和临床前评估到安全性和可能的​​临床功效试验。因此，它们涵盖了儿科装置开发的范围。该财团还建议开发用于评估儿童神经发育和生活质量的临床工具，这些工具可用作将来的儿科设备试验的模型。 PCDC的优势是儿科临床和多中心试验专业知识，小儿设备的工程知识以及专门针对儿童医疗设备的监管专业知识和商业化记录。