Medtronic has announced that the Resolute Integrity coronary drug-eluting stent (DES) system has received European regulatory approval for several new indications.
The Resolute Integrity DES is now indicated in countries outside the U.S. that accept the CE Mark for the following patient and lesion types: acute coronary syndromes, acute MI, unstable angina, diabetes mellitus, bifurcations, multi-vessel disease, total occlusions, chronic total occlusions and in-stent restenosis. All but the indications for diabetes and multi-vessel disease are new.
Two of the studies that contributed to the European regulatory authority’s approval of these indications, RESOLUTE All Comers and RESOLUTE International, are the subject of several new data presentations at EuroPCR in Paris, May 15-28.
Medtronic is based in Minneapolis.