Xience Xpedition SV 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 Vascular Inc 3200 Lakeside Drive, Santa Clara, CA, 95054 United States Of America

Therapeutic area:

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

Therapeutic indications:

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 antiproliferative 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. The XIENCE Xpedition Everolimus SV Eluting Coronary Stent System ise 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. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, or 28 mm) with a reference vessel diameter of ? 2.25 mm and ? 2.5 mm.

Authorization status:

A

Authorization date:

2013-10-02