More Testing for CE Marks

Dr Doug Fraser
Consultant Cardiologist
Manchester Heart Centre
Manchester Royal Infirmary
MANCHESTER

Is there any need for additional stents on the market, or is the latter already saturated?

Design of workhorse stents by the major companies is continuing and new designs will continue to bring improvements. These incremental improvements will be less than the major advances we have seen in the past and it is uncertain whether major breakthroughs in design such as dissolving platforms will work. Design and testing of workhorse stents is likely to remain with the larger companies. Stents designed for niche applications such as dedicated bifurcation, STEMI and left main stents will continue and do show promise. We may therefore see more development here. To answer your question, there is little point in having many more platforms that do the same as current ones but advances in design will continue, perhaps particularly in the niche designs.

Should there be more rigorous testing before CE Marks are handed out?

To require a mega-trial before adoption of every new stent platform would exclude smaller companies from developing niche stents and so would stifle innovation so there needs to be balance – but I do agree that the CE marking process could be more rigorous and certainly better standardized.