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Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies
Sophie C Hofferberth1, Timothy Kelley2, Aimee K Armstrong3
1Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Autus Valve Technologies, Inc, Boston, Massachusetts.
Background:
In October 2022, the Heart Valve Collaboratory and United States Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies.
Methods:
The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers, and scientists were assembled to review the current state of the art, discuss unique challenges in the premarket and postmarket evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease.
Results:
The workshop highlighted the tremendous clinical need to develop a new framework for developing and evaluating pediatric-specific heart valve therapies.
Conclusions:
This report summarizes the proceedings of the workshop and outlines the key considerations for developing a new framework for evaluating novel pediatric heart valve therapies.
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