کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2980294 1578618 2013 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی کاردیولوژی و پزشکی قلب و عروق
پیش نمایش صفحه اول مقاله
A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves
چکیده انگلیسی

ObjectiveCongenital 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.MethodsIn 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.ResultsRecommendations, derived from ISO 5840:2005 and the 2010 FDA Draft Replacement Heart Valve Guidance, are provided for hydrodynamic, durability, and fatigue testing.ConclusionsThe 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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: The Journal of Thoracic and Cardiovascular Surgery - Volume 146, Issue 4, October 2013, Pages 879–886
نویسندگان
, , , , , , , ,