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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Abbott Vascular Division of Abbott Medical Australia Pty Ltd

classe:

Class III

Fabriqué par:

Abbott Vascular Inc 3200 Lakeside Drive, SANTA CLARA, CA, 95054 United States Of America

Domaine thérapeutique:

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

indications thérapeutiques:

Stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. The XIENCE PRIME LL 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 two different lengths are available. Drug dose (micrograms) varies with stent size. 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, due vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels (RVD equal to or < 2.77 mm), and in lesions where treatment results in the jailing of side branches (lesion with a side branch < 2 mm in diameter or equal

Statut de autorisation:

A

Date de l'autorisation:

2010-01-05