SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
09-11-2017

Dostopno od:

Boston Scientific Pty Ltd

Razred:

Class III

Izdeluje:

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

Terapevtsko območje:

58771 - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Terapevtske indikacije:

The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System 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 SYNERGY Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including patients with acute myocardial infarction, due to discrete de novo native coronary artery lesions. This device is MR conditional.

Status dovoljenje:

A

Datum dovoljenje:

2014-02-21

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