Regulation of medical devices in the european union and USA: The case of coronary drug-eluting stents

INTRODUCTION: Complex regulatory systems were implemented in the European Union (EU) and the United States (US) to regulate medical devices. There are differences in pre-marketing and post-marketing regulation of medical devices in EU and the US that result in different approval times, and different levels of efficacy and safety information available for reimbursement and clinical decision-making. A coronary drug eluting stent (DES) is a new technology that combines the use of a medical device (i.e. stent) and a drug. OBJECTIVES: The objectives of this study were to analyze differences in approval time and pre-marketing approval requirements and clinical information for drug eluting coronary stents (DES) approved by the US Food and Drug Administration (FDA) and receiving CE Marking in the EU in the period 2003- 2012. METHODS: Medical device data derived from FDA and a review of the literature. Clinical trials information was derived from clinicaltrials.gov. The study assessed differences in approval dates and clinical trials for drug eluting coronary stents in the EU and the US. Descriptive statistics were used to compare differences between both systems. RESULTS: The FDA listed 376 important new medical devices authorized in the period 2003-2012, an estimated 4.0% (n=15) of those devices were DES sponsored by 4 different companies. Pre-marketing approval of DES (n=15) occurred in an average 30.48±23.15 months earlier in the EU than in the US. DES authorized by the FDA had an average of 2.73±1.53 clinical trials completed at the moment of marketing authorization with an average of 2.117±1,471 patients enrolled. DES authorized by the EU had an average of 1.93±1.39 clinical trials completed at the moment of CE mark with an average of 1.016±671 patients enrolled. CONCLUSIONS: There are important differences in the regulation of medical devices in the EU and the US that resulted in differences in safety and efficacy requirements for pre-marketing approval of medical devices in both systems. FDA required a significant larger number of clinical trials and patients enrolled in clinical research before granting marketing authorization to new DES. European patients have early access to new devices, but less clinical information available for reimbursement and medical decisions.