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

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Abbott Vascular Division of Abbott Medical Australia Pty Ltd

Classe:

Class III

Prodotto da:

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

Area terapeutica:

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

Indicazioni terapeutiche:

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. 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 (lesi

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2010-01-05