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

Intended purpose

The XIENCE Xpedition™ 48 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. In all cases, the treated lesion length should be less than the nominal stent length (48 mm) with a reference vessel diameter of ≥ 2.50 mm and ≤ 3.75 mm.

Functional description

A balloon expandable, drug coated stent pre-mounted on rapid exchange delivery system. Stent acts as scaffold to open the blockage in artery; polymers coated over stent provide a drug reservoir and control release profile of the anti-proliferative drug. Two radiopaque markers underneath balloon mark working length of balloon and expanded stent length. Two proximal delivery system shaft markers indicate relative position of delivery system to the brachial or femoral guiding catheter.