High-Risk Medical Devices, Children and the FDA: Regulatory Challenges Facing Pediatric Mechanical Circulatory Support Devices

Author:

Almond Christopher S.D.,Chen Eric A.,Berman Michael R.,Less Joanne R.,Baldwin J Timothy,Linde-Feucht Sarah R.,Hoke Tracey R.,Pearson Gail D.,Jenkins Kathy,Duncan Brian W.,Zuckerman Bram D.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Biomedical Engineering,General Medicine,Biomaterials,Bioengineering,Biophysics

Reference20 articles.

1. Outcome of listing for heart transplantation in infants younger than six months: Predictors of death and interval to transplantation. The Pediatric Heart Transplantation Study Group.;Morrow;J Heart Lung Transplant,1997

2. Mechanical circulatory support for infants and children with cardiac disease.;Duncan;Ann Thorac Surg,2002

3. Use of extracorporeal life support as a bridge to pediatric cardiac transplantation.;Gajarski;J Heart Lung Transplant,2003

4. Use of assist devices and ECMO to bridge pediatric patients with cardiomyopathy to transplantation.;Levi;J Heart Lung Transplant,2002

5. Use of extracorporeal membrane oxygenation in pediatric thoracic organ transplantation.;Kirshbom;J Thorac Cardiovasc Surg,2002

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