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A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves
Ajit P Yoganathan1, Mark Fogel, Susan Gamble
1The Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, Ga.
Insights
Developing pediatric prosthetic heart valves requires specific guidance for design and testing. This consensus provides a framework for evaluating these critical devices for children with congenital heart valve disease.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Regulatory Science
Background:
- Congenital heart valve disease is a common pediatric condition with limited treatment options.
- Currently, no Food and Drug Administration (FDA)-approved prosthetic heart valves exist for pediatric use.
- Pediatric patients are often excluded from adult heart valve trials.
Purpose of the Study:
- To establish consensus on pediatric definitions, design, in vitro testing, and clinical trials for pediatric prosthetic heart valves.
- To guide the development of safe and effective prosthetic heart valves for children.
- To address the need for FDA-approved pediatric valve devices.
Main Methods:
- A 2010 workshop convened heart valve manufacturers, pediatric clinicians, academicians, and FDA staff.
- The workshop aimed to identify methods for evaluating pediatric prosthetic valves and conducting clinical trials.
- Recommendations were derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance.
Main Results:
- Specific recommendations for hydrodynamic, durability, and fatigue testing were developed.
- The consensus addresses in vitro testing protocols.
- Guidance is provided for premarket and postmarket clinical studies.
Conclusions:
- The article offers a framework for manufacturers seeking regulatory approval for pediatric prosthetic heart valves.
- It emphasizes the importance of in vitro and clinical studies for pediatric valve designs.
- This guidance aims to facilitate the approval process for pediatric heart valve replacements.
Objective:
Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication.
Methods:
In stark contrast to the various designs of adult-sized replacement valves available in the market, there are no Food and Drug Administration (FDA)-approved prosthetic heart valves available for use in the pediatric population. There is a pressing need for FDA-approved pediatric valve devices in the United States. The pediatric patient population has been typically excluded from replacement heart valve trials for several reasons. In January 2010, heart valve manufacturers and pediatric clinicians collaborated with academicians and FDA staff in a workshop to suggest ways to successfully evaluate pediatric prosthetic valves and conduct pediatric clinical trials to provide acceptable heart valve replacement options for this patient population.
Results:
Recommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing.
Conclusions:
The article specifically addresses in vitro and premarket and postmarket approval clinical studies that should be considered by a heart valve manufacturer for obtaining regulatory approval of pediatric sizes of prosthetic heart valve designs that are already approved for adult clinical use.
