Document Detail

Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
MedLine Citation:
PMID:  23206981     Owner:  NLM     Status:  In-Data-Review    
The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the United States Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients who have advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Inter-agency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and Interagency Registry of Mechanically Assisted Circulatory Support.
Michael A Acker; Francis D Pagani; Wendy Gattis Stough; Douglas L Mann; Mariell Jessup; Robert Kormos; Mark S Slaughter; Timothy Baldwin; Lynne Stevenson; Keith D Aaronson; Leslie Miller; David Naftel; Clyde Yancy; Joseph Rogers; Jeffrey Teuteberg; Randall C Starling; Bartley Griffith; Steven Boyce; Stephen Westaby; Elizabeth Blume; Peter Wearden; Robert Higgins; Michael Mack
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation     Volume:  31     ISSN:  1557-3117     ISO Abbreviation:  J. Heart Lung Transplant.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-04     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9102703     Medline TA:  J Heart Lung Transplant     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1241-52     Citation Subset:  IM    
Copyright Information:
Copyright © 2012. Published by Elsevier Inc.
Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address:
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