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

BMC Cardiovascular Disorders

Research Article

Ingrid Zechmeister¹  Claudia Wild¹  Judit Erdös¹ 

[1] Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Garnisongasse 7/20, 1090, Vienna, Austria;

关键词: Approval;    Market authorisation;    Medical devices;    Evidence based medicine/EbM;    Health Technology Assessment/HTA;    Cardio-vascular disease;    Surgery;    Safety;   

DOI  :  10.1186/1471-2261-14-154

 received in 2014-09-19, accepted in 2014-10-21,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundEuropean 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.MethodsSince 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.Results10 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.ConclusionsMarket 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.

【 授权许可】

CC BY   
© Wild et al.; licensee BioMed Central Ltd. 2014