Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradabl

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Disponible depuis:

Boston Scientific Pty Ltd

classe:

Class III

Fabriqué par:

Boston Scientific Corporation 300 Boston Scientific Way, Marlborough, MA, 01752 United States Of America

Domaine thérapeutique:

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

indications thérapeutiques:

The Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. The balloon is then inflated to expand the stent to the appropriate diameter. Finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. The Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including patients with acute myocardial infarction and patients with concomitant diabetes mellitus, due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm,28 mm, 32 mm and 38 mm) with a reference vessel diameter of 2.25 mm - 4.00 mm.

Statut de autorisation:

Included