Report on Evaluation of Coronary Stents in Europe
- Byrne RA, Serruys PW, Baumbach A, et al.
- Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions Task Force on the Evaluation of Coronary Stents in Europe: Executive Summary. Eur Heart J 2015;Jun 13:[Epub ahead of print].
The following are 10 points to remember from a report on the evaluation of coronary stents in Europe, developed by the European Society of Cardiology (ESC)-European Association of Percutaneous Cardiovascular Interventions (EAPCI) Task Force:
- The life cycle of coronary stents is short due to rapid device iteration and innovation, which can make early-generation devices clinically obsolete in 5 years.
- The Task Force emphasizes that the premarket approval process should be as efficient as possible in order that timely access to improved devices for patients is maintained.
- The Task Force considers timely response and review of submitted files essential for a successful approval process. It recommends that the review process should be monitored and completed within a prespecified time—ideally within 3–6 months.
- The Task Force recognizes that under ideal circumstances, devices should be categorized into conventional devices (alternative treatment with well-established standard-of-care available) and innovative devices (no or limited treatment with established standard-of-care available). However, this distinction may be difficult and in order to avoid ambiguity, the Task Force concludes that a uniform assessment pathway remains preferable.
- The Task Force acknowledges the critical role of post-marketing surveillance in the overall clinical evaluation process. In particular, there is concern of underreporting of serious adverse events related to malfunction of medical devices following market approval.
- The Task Force recommends a uniform process with consistent quality parameters leading to pre- and post-marketing device approval based on findings of the systematic review.
- The Task Force proposes objective performance criteria evaluation of coronary artery stents during early clinical investigation.
- The Task Force proposes systematic public registration for all clinical investigations leading to CE approval, publication of decision-making process of notified bodies that lead to conditional and full CE approval of medical devices on a publicly accessible website, publication of the results of all post-marketing surveillance studies initiated for full CE approval, and creation of a central publically accessible database of all coronary stents with CE approval and related clinical trial evidence.
- The Task Force recommends recruiting a minimum of half of all patients in Europe for clinical trials with medical devices intended to support application for CE-mark approval.
- The instructions for use should provide clear guidance as to the appropriate indications and contraindications for a particular device.
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