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

Intended purpose

The XIENCE PRIME SV Everolimus Eluting Coronary Stent System is 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, 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 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 SV Everolimus Eluting Coronary Stent Systems are also indicated for improving peripheral luminal diameter in the following: " For 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 8mm,12mm,15mm,18mm, 23mm, or 28mm) with a reference vessel diameter of 2.5 - 4.25 mm.

Functional description

Stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. The XIENCE PRIME SV is intended to deliver and deploy a balloon expandable, drug coated metal stent in the de novo and restenotic native coronary arteries. Six different lengths of 2.25mm diameter stent are available. Drug dose (micrograms) varies with stent length.