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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abbott Vascular Division of Abbott Medical Australia Pty Ltd

Class:

Class III

Manufactured by:

Abbott Medical 3200 Lakeside Drive, Santa Clara, California, 95054 United States Of America

Therapeutic area:

56284 - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Therapeutic indications:

Xience Alpine is a pre-mounted L-605 cobalt chromium (CoCr) alloy stent with a coating that consists of a blend of the anti-proliferative drug everolimus and polymers. Two radiopaque markers, located underneath the balloon, fluoroscopically mark the working length of the balloon and the expanded stent length. Two proximal delivery system shaft markers indicate relative position of delivery system to the end of the brachial or femoral guiding catheter. The XIENCE Alpine? 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 (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of ? 2.00 mm and ? 4.25 mm.

Authorization status:

A

Authorization date:

2015-12-16