title: Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.
abstract: BACKGROUND
  European medical device regulation is under scrutiny and will be re-regulated with stricter rules concerning requirements for clinical evidence for high-risk medical devices. It is the aim of this study to analyse the differences between Europe and USA in dealing with risks and benefits of new cardio-vascular devices.
  
  
  METHODS
  Since no information is available on clinical data used by the Notified Body for CE-marking, data from Austrian pre-reimbursement assessments close to European market approval were used as proxy and compared with clinical data available at time of market approval by FDA in the USA.
  
  
  RESULTS
  10 cardio-vascular interventions with 27 newly CE approved medical devices were analysed. The time lag between market authorisation in Europe and in the USA is 3 to 7 years. Only 7 CE-marked devices also hold a FDA market approval, 7 further devices are in FDA approved ongoing efficacy trials. For 4 of the CE-marked devices the FDA market application or the approval-trial was either suspended due to efficacy or safety concerns or the approval was denied. Evidence available at time of CE-marking are most often case-series or small feasibility RCTs, while large RCTs and only in rare cases prospective cohort studies are the basis of FDA approvals. Additionally, the FDA often requires post-approval studies for high-risk devices.
  
  
  CONCLUSIONS
  Market authorisation based on mature clinical data deriving from larger RCTs and longer follow-ups do not only change the perspective on the risk-benefit ratio, but also secures real patient benefit and safety and assures payers of investing only in truly innovative devices.
authors.affiliation: Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Garnisongasse 7/20, 1090 Vienna, Austria. Claudia.wild@hta.lbg.ac.at.
authors.forename: Claudia
authors.initials: C
authors.lastname: Wild
authors.forename: Judit
authors.initials: J
authors.lastname: Erdös
authors.forename: Ingrid
authors.initials: I
authors.lastname: Zechmeister
mesh_terms: D001317:Austria; D002309:Cardiology / Q000295:instrumentation*; D018795:Device Approval; D004059:Diffusion of Innovation; D004867:Equipment Design; D004869:Equipment Safety; D019317:Evidence-Based Medicine / Q000379:methods*; D006801:Humans; D008389:Marketing of Health Services; D061214:Patient Safety; D018570:Risk Assessment; D012307:Risk Factors; D013673:Technology Assessment, Biomedical / Q000379:methods*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration