Title: Characterization and Utilization of Therapeutic Cardiac Devices in Children with Congenital Heart Disease

Technology of Interest: Cardiovascular Device

Disease Area: Cardiovascular

Duration: 12 months

Network Collaborator(s): PEDSnet

This project aims to determine whether data capture of device utilization in a Pediatric Cardiac Catheterization Laboratory is possible across multiple different institutions.  This pilot study is designed to begin to devise a global approach which will ultimately be applied across institutions and networks.

This Test-Case aims to determine if NESTcc could adequately capture a specific stent implantation in pulmonary arteries and systemic veins during congenital heart disease therapy.  The stents being studied are of particular interest in pediatric patients.  Successful implantation and use surveillance could provide the impetus for more robust outcome assessment, and subsequent possible label expansion.  In addition, this project will characterize the range of pediatric stent use at participating PEDSnet sites and develop a scalable approach to investigating pediatric device use in PCORnet networks.  Formal regulatory (U.S. Food and Drug Administration – FDA) approval for devices used in congenital heart disease is rare, and the majority are used “off-label” after adult approval.  The lack of formal regulatory authorization, and the potential cost of separate pediatric studies has undermined industry development, and constrained therapies in the pediatric space.  This study would allow prevalence information to be collected across a consortium of multiple institutions.  System protocols and conventions already established by NESTcc would serve as an ideal framework in the initial real-time phase of this project.

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Today at 4:30 p.m. CT, NESTcc Chief of Staff @RachelRRath will present at the 5th Annual Evening of Pediatric Device Innovation, joining experts from Houston and across the country to discuss real world evidence (RWE). More: bit.ly/2DRlny0 pic.twitter.com/v5rhJ1qZBU 2 days ago

At the FDA/CMS Summit today at 4:30 p.m., join Data Network Director @robbert_z for a panel discussion on expanding the role of real-world evidence and patient-reported outcomes in regulatory decision-making. #RWE More: bit.ly/360vmgv pic.twitter.com/DcGyCnCCOD 4 days ago

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