Stentys' self-apposing cardiac stent gains expanded CE mark indications

Stentys now has key CE mark approval to use its self-apposing stent to treat acute heart attacks in a broader class of patients. The new indications open up the stent's use for patient subsets including those with tapered, aneurysmatic, dilated or very large vessels, or those with bypass grafts. In addition, the regulatory changes lift use restrictions for chronic total occlusions and left main bifurcations. Stentys' self-apposing stent has had its initial CE mark since 2010, but the French company said the new market segments reflect about 10% of all percutaneous coronary interventions in Europe. Release