Pediatric Cardiovascular Device Consortium

描述（由申请人提供）： 儿科器械的开发和评估已被公认为是改善先天性和后天性疾病儿童生活和福利的关键需求。器械开发商和制造商面临的众多挑战导致对儿科器械（特别是心血管器械）的大量需求未得到满足。儿科心血管器械联盟（PCDC）的目的是在新型儿科心脏器械开发的每个必要步骤中为器械开发商和制造商提供专业知识和资源，以加快创新步伐。PCDC是一个由工程、心脏临床科学、临床试验设计和性能、设备开发专家和行业合作伙伴组成的合作组织，其目标是开发和评估针对心血管缺陷儿童的新疗法。该联盟是美国国立卫生研究院（NIH）赞助的试验组（儿科心脏网络（PHN））、数据协调中心（NERI）、专门针对儿科器械的工程专业知识（格鲁吉亚理工学院，GIT）以及监管和商业化专业知识（NERI、GIT和儿童医院技术开发办公室（TIDO））之间的合作伙伴关系。PHN是一个由8个核心和13个卫星儿科临床中心组成的工作组，这些中心在PHN申办的临床试验中有成功合作的记录。该申请建议在初始阶段支持四个项目：1。儿童生物可吸收瓣膜成形环（Bioring）; 2.儿科超声成像开发（Philips）; 3.儿科循环辅助装置临床评价（Levitronix）;和4.先天性心脏瓣膜收紧项目（GIT）。这些项目的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疗效试验。因此，它们涵盖了儿科器械开发的范围。该联盟还建议开发用于评估儿童神经发育和生活质量结局的临床工具，这些工具可用作未来儿科器械试验的模型。PCDC的优势在于儿科临床和多中心试验专业知识、儿科器械工程知识以及专门针对儿童医疗器械的监管专业知识和商业化记录。

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.