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

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Διαθέσιμο από:

Abbott Vascular Division of Abbott Medical Australia Pty Ltd

Kατηγορία:

Class III

Κατασκευάζεται από:

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

Θεραπευτική περιοχή:

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

Θεραπευτικές ενδείξεις:

Stenting system for coronary arteries, supplied pre-loaded onto an angioplasty balloon catheter. The XIENCE PRIME 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 six different lengths are available. Drug dose (micrograms)varies with stent size. The XIENCE PRIME? 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 s

Καθεστώς αδειοδότησης:

A

Ημερομηνία της άδειας:

2010-01-05