The FDA has approved the Resolute Integrity drug-eluting stent (DES), the first such stent to carry an indication for use in diabetics with coronary artery disease, according to a statement from the manufacturer.
The approval for the Integrity stent was based on data from trials utilizing the Resolute DES. Although both stents are approved, Medtronic intends to market only the Integrity in the U.S., according to a spokesperson.
Both stents use the same combination of drug (zotarolimus) and polymer (BioLinx), but the Resolute Integrity is more flexible than the Resolute. This can be especially important for diabetic patients whose coronary arteries tend to be narrower than those in patients without diabetes.
Diabetics account for about 30% of the one million patients in the U.S. who undergo a percutaneous coronary intervention (PCI), the company said.