000			03937nam a22004097a 4500
008			130917s20122012 xxu||||| |||| 00| 0 eng dOvid Technologies
022			_a0003-4975
040			_aOvid MEDLINE(R)
099			_a23153481
245			_aStatement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States. [Review]
251			_aAnnals of Thoracic Surgery. 94(6):2147-58, 2012 Dec.
252			_aAnn Thorac Surg. 94(6):2147-58, 2012 Dec.
253			_aThe Annals of thoracic surgery
260			_c2012
260			_fFY2013
266			_d2013-09-17
501			_aAvailable online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007
520			_aThe incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US 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, Interagency 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. Copyright 2012 The Society of Thoracic Surgeons, American Heart Association, Inc, and International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
546			_aEnglish
650			_a*Device Approval/st [Standards]
650			_a*Heart Failure/th [Therapy]
650			_a*Heart-Assist Devices/st [Standards]
650			_a*Product Surveillance, Postmarketing/mt [Methods]
650			_a*Registries
650			_aHeart Transplantation/mt [Methods]
650			_aHeart Transplantation/st [Standards]
650			_aHumans
650			_aUnited States
650			_aUnited States Food and Drug Administration
651			_aMedStar Heart & Vascular Institute
657			_aJournal Article
657			_aReview
700			_aBoyce, Steven W
790			_aAaronson KD, Acker MA, Baldwin T, Blume E, Boyce S, Griffith B, Higgins R, Jessup M, Kormos R, Mack M, Mann DL, Miller L, Naftel D, Pagani FD, Rogers J, Slaughter MS, Starling RC, Stevenson L, Stough WG, Teuteberg J, Wearden P, Westaby S, Yancy C
856			_uhttp://dx.doi.org/10.1016/j.athoracsur.2012.09.040 _zhttp://dx.doi.org/10.1016/j.athoracsur.2012.09.040
942			_cART _dArticle
999			_c1109 _d1109