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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. The Task Force proposes objective performance criteria evaluation of coronary artery stents during early clinical investigation.
  8. 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.
  9. 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.
  10. The instructions for use should provide clear guidance as to the appropriate indications and contraindications for a particular device.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Coronary Vessels, Device Approval, Drug-Eluting Stents, Europe, Percutaneous Coronary Intervention, Stents

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