TY - JOUR
T1 - Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the united states Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the united states
AU - Acker, Michael A.
AU - Pagani, Francis D.
AU - Stough, Wendy Gattis
AU - Mann, Douglas L.
AU - Jessup, Mariell
AU - Kormos, Robert
AU - Slaughter, Mark S.
AU - Baldwin, Timothy
AU - Stevenson, Lynne
AU - Aaronson, Keith D.
AU - Miller, Leslie
AU - Naftel, David
AU - Yancy, Clyde
AU - Rogers, Joseph
AU - Teuteberg, Jeffrey
AU - Starling, Randall C.
AU - Griffith, Bartley
AU - Boyce, Steven
AU - Westaby, Stephen
AU - Blume, Elizabeth
AU - Wearden, Peter
AU - Higgins, Robert
AU - Mack, Michael
N1 - Funding Information:
The authors report the following disclosures: Keith D. Aaronson, MD, research support and speaker fees from HeartWare International, Inc; Michael A. Acker, MD, consultant for Thoratec Corporation; Timothy Baldwin, PhD, no disclosures; Steven Boyce, MD, educational grants from and stock ownership in Thoratec Corporation and HeartWare International, Inc; Elizabeth Blume, MD, no disclosures; Bartley Griffith, MD, no disclosures; Robert Higgins, MD, no disclosures; Mariell Jessup, MD, research on investigational mechanical circulatory support devices within the past 5 years (uncompensated); Robert Kormos, MD, no disclosures; Michael Mack, MD, no disclosures; Douglas L. Mann, MD, no disclosures; Leslie Miller, MD, no disclosures; David Naftel, PhD, Berlin Heart, Inc and HeartWare International, Inc; Francis D. Pagani, MD, PhD, national principal investigator, HeartWare Endurance trial, and national coprincipal investigator, NHLBI REVIVE-IT trial; Joseph Rogers, MD, consultant for Thoratec Corporation and national principal investigator, HeartWare Endurance trial; Mark S. Slaughter, MD, training and educational grant support from Thoratec Corporation and HeartWare International, Inc; Randall C. Starling, MD, MPH, member ROADMAP Steering Committee, and travel reimbursement (<$5,000 per annum) from Thoratec Corporation; Lynne Stevenson, MD, no disclosures; Wendy Gattis Stough, PharmD, no disclosures; Jeffrey Teuteberg, MD, no disclosures; Peter Wearden, MD, PhD, no disclosures; Stephen Westaby, MD, PhD, Medical Director, Calon Cardiotechnology Corporation (uncompensated); and Clyde Yancy, MD, no disclosures.
PY - 2013/1
Y1 - 2013/1
N2 - The 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.
AB - The 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.
KW - AHA Scientific Statements
KW - Heart failure
KW - Heart-assist device
UR - http://www.scopus.com/inward/record.url?scp=84873695215&partnerID=8YFLogxK
U2 - 10.1161/HHF.0b013e318279f6b5
DO - 10.1161/HHF.0b013e318279f6b5
M3 - Article
C2 - 23149497
AN - SCOPUS:84873695215
SN - 1941-3289
VL - 6
SP - e1-e11
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
IS - 1
ER -