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

Intended purpose

The XIENCE PRIME™ Everolimus Eluting Coronary Stent System is indicated for improving coronary artery 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, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ≥ 65), and for treatment of both men and women. • For treatment of patients with high bleeding risk (HBR) under dual antiplatelet therapy (DAPT) as short as 28 days. • For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with TIMI flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. The XIENCE PRIME Everolimus Eluting Coronary Stent Systems are also indicated for improving peripheral luminal diameter in patients with severe claudication or critical limb ischemia (CLI) due to infrapopliteal occlusive lesions. In all cases, the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of ≥ 2.25 mm and ≤ 4.25 mm.

Functional description

Stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. The XIENCE PRIME 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 six different lengths are available. Drug dose (micrograms)varies with stent size.