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。儿科心血管设备联盟是一个由工程学、心脏临床科学、临床试验设计和性能专家、设备开发专家和行业合作伙伴组成的合作组织，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赞助的试验小组(儿科心脏网络)、数据协调中心(新英格兰研究所)、专门针对儿科设备的工程专业知识(佐治亚理工学院)以及监管和商业化专业知识(新英格兰研究所、佐治亚理工学院和波士顿儿童医院技术开发办公室)之间的合作伙伴关系。联盟伙伴关系已经在几个儿科心脏设备开发项目中帮助发明家、制造商和设备开发商。在初始阶段将支持四个项目：1.用于儿童的微型植入式传感器；2.用于Fontan生理学失败儿童的循环辅助插管系统；3.儿科超声成像和外科计划工具(飞利浦)；以及4.儿科循环辅助装置临床评估(Levitronix)。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。优势 儿科心血管设备联盟的成员包括儿科临床和多中心试验专业知识、儿科设备工程知识、监管专业知识和商业化专业知识，以及协助各种发明家、设备制造商和开发商将儿童设备推向市场的记录。

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 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 Pediatric Cardiovascular Device Consortium is a collaborative of experts in engineering, cardiac clinical sciences, clinical trial 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 sponsored trial group (Pediatric Heart Network), Data Coordinating Center (New England Research Institute), engineering expertise specifically in pediatric devices (Georgia Institute of Technology) and regulatory and commercialization expertise (New England Research Institute, Georgia Institute of Technology, and Boston Children's Hospital technology development office). The Consortium Partnership has already assisted inventors, manufacturers and device developers in several pediatric cardiac device development projects. Four projects will be supported in the initial phase: 1. A miniaturized implantable sensor for children; 2. A circulatory assist cannula system for children with failing Fontan physiology; 3. Pediatric ultrasound imaging and surgical planning tool (Philips); and 4. Pediatric circulatory assist device clinical evaluation (Levitronix). These projets 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 strengths of the Pediatric Cardiovascular Device Consortium are the pediatric clinical and multicenter trials expertise, engineering knowledge in pediatric devices, regulatory expertise and commercialization expertise and a track record of assisting a diverse group of inventors, device manufacturers, and developers in moving devices for children to the market.