Pediatric Cardiovascular Device Consortium

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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.