title: Statement regarding the pre and post market assessment of durable, implantable ventricular assist devices in the United States.
abstract: 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.
authors.affiliation: Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania, USA. michael.acker@uphs.upenn.edu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Acker
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.forename: Wendy Gattis
authors.initials: WG
authors.lastname: Stough
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Mann
authors.forename: Mariell
authors.initials: M
authors.lastname: Jessup
authors.forename: Robert
authors.initials: R
authors.lastname: Kormos
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.forename: Timothy
authors.initials: T
authors.lastname: Baldwin
authors.forename: Lynne
authors.initials: L
authors.lastname: Stevenson
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.forename: Leslie
authors.initials: L
authors.lastname: Miller
authors.forename: David
authors.initials: D
authors.lastname: Naftel
authors.forename: Clyde
authors.initials: C
authors.lastname: Yancy
authors.forename: Joseph
authors.initials: J
authors.lastname: Rogers
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Teuteberg
authors.forename: Randall C
authors.initials: RC
authors.lastname: Starling
authors.forename: Bartley
authors.initials: B
authors.lastname: Griffith
authors.forename: Steven
authors.initials: S
authors.lastname: Boyce
authors.forename: Stephen
authors.initials: S
authors.lastname: Westaby
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Blume
authors.forename: Peter
authors.initials: P
authors.lastname: Wearden
authors.forename: Robert
authors.initials: R
authors.lastname: Higgins
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D004867:Equipment Design; D005060:Europe; D006333:Heart Failure / Q000628:therapy; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007564:Japan; D011358:Product Surveillance, Postmarketing; D012042:Registries; D014481:United States