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

Ingrid Zechmeister¹  Judit Erdös¹  Claudia Wild¹ 

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

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

Others  :  1088712
DOI  :  10.1186/1471-2261-14-154

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

【 摘 要 】

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.

【 授权许可】

   
2014 Wild et al.; licensee BioMed Central Ltd.

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