Pediatric Cardiovascular Device Consortium

描述（由申请人提供）：

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.