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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.
Insights
Developing new heart valve technologies for children is crucial. A global workshop identified the need for a new framework to accelerate the development and evaluation of pediatric heart valve therapies.
Area of Science:
- Biomedical Engineering
- Cardiovascular Research
- Pediatric Medicine
Background:
- A global workshop convened by the Heart Valve Collaboratory and FDA in October 2022 addressed the critical need for pediatric heart valve technologies.
- Current technologies lack pediatric-specific designs, creating an unmet clinical need for improved treatments for children with heart valve disease.
Purpose of the Study:
- To address the unmet clinical need for pediatric heart valve technologies.
- To accelerate the development and evaluation of novel pediatric heart valve therapies.
Main Methods:
- Convened a global multidisciplinary workshop in October 2022.
- Assembled key stakeholders: pediatric cardiologists, cardiac surgeons, valve manufacturers, engineers, and scientists.
- Reviewed the current state of pediatric valve technology and discussed premarket/postmarket evaluation challenges.
Main Results:
- Highlighted a significant clinical need for a new framework for developing pediatric-specific heart valve therapies.
- Identified emerging technologies with potential to address unmet needs in pediatric valve disease.
Conclusions:
- A new framework is essential for developing and evaluating novel pediatric heart valve therapies.
- The workshop proceedings provide key considerations for establishing this new evaluation framework.
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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