Pediatric Cardiovascular Device Consortium

描述(由申请人提供)： 儿科设备的开发和评估已被认为是改善患有先天性和后天性疾病的儿童的生活和福利的迫切需要。设备开发商和制造商面临的众多挑战导致了对儿科设备，特别是心血管设备的大量未得到满足的需求。儿科心血管设备联盟(PCDC)的目标是为设备开发商和制造商提供专业知识和资源，帮助他们完成新型儿科心脏设备开发的每一个必要步骤，以加快创新步伐。PCDC是一个由工程学、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协作体，其目标是为患有心血管缺陷的儿童开发和评估新疗法。该联盟是由美国国立卫生研究院(NIH)赞助的试验小组(儿科心脏网络(PHN))、数据协调中心(NERI)、专门针对儿科设备的工程专业知识(佐治亚理工学院，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个核心儿科临床中心和13个卫星儿科临床中心组成的工作组，在PHN赞助的临床试验中有成功合作的记录。申请提出在初始阶段支持四个项目：1.儿童生物可吸收瓣膜成形术环(BIORING)；2.儿科超声成像开发(飞利浦)；3.儿科循环辅助装置临床评估(Levitronix)；以及4.先天性心脏瓣膜捆绑项目(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，它们涵盖了儿科设备开发的范围。该联盟还建议开发临床工具来评估儿童的神经发育和生活质量结果，这可以作为未来儿科设备试验的模型。PCDC的强项是儿科临床和多中心试验的专业知识、儿科设备的工程知识，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。

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.