January 28, 2013

Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States: Executive Summary: 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 the Interagency Registry of Mechanically Assisted Circulatory Support.


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A panel of experts convened to discuss topics relevant to promoting an environment of safe and effective introduction of new technologies for mechanical cirulatory support. The focus of this Statement Paper includes : (1) innovative clinical trial designs; (2) the need for a new encompassing indication for therapy to facilitate device evaluation and reduce disparities in patient access; (3) assessing appropriateness of international standards for regulatory evaluation of MCS devices; (4 ) exploring methods for preclinical MCS device evaluation; and (5) development and regulatory oversight of MCS devices in
the pediatric population.

Cardiac Transplantation

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