XIENCE Prime LL Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Intended purpose

Indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions; for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset; for the treatment of patients with concomitant diabetes, acute coronary syndrome, due vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels (RVD equal to or < 2.77 mm), and in lesions where treatment results in the jailing of side branches (lesion with a side branch < 2 mm in diameter or equal to or >2mm in diameter with an ostial stenosis < 50%) and for the treatment of elderly patients (age equal to or > 65), and women (female gender); also indicated for improving peripheral luminal diameter in the following: In the treatment of severe claudication or critical limb ischemia (CLI) due to infrapopliteal occlusive lesions. The treated lesion length should be less than the nominal stent length (33 - 38mm) with a reference vessel diameter of 2.5 - 4.0mm.

Functional description

Stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. The XIENCE PRIME LL is intended to deliver and deploy a balloon-expandable, drug coated metal stent in the de novo and restenotic native coronary arteries. Five different stent diameters in two different lengths are available. Drug dose (micrograms) varies with stent size.