Firehawk Liberty Rapamycin Target Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Microport Crm Pty Ltd

Class:

Class III

Manufactured by:

Shanghai MicroPort Medical Group Co Ltd 1601 Zhangdong Road ZJ Hi-Tech Park, Shanghai, 201203 China

Therapeutic area:

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

Therapeutic indications:

The product is a device/drug combination product consisting of a) a stent coated with rapamycin in a biodegradable polymer which filled in grooves on the outer surface of stent struts; and b)a rapid exchange (RX) delivery catheter. The stent is left in the vessel to permanently support the vessel. Rapamycin is abluminal on stent struts and is slowly eluted to inhibit proliferation of smooth muscle cells. The coating will degrade and eventually the stent becomes a metal stent. The Firehawk Liberty? Rapamycin Target Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ? 60 mm) with reference vessel diameters of ? 2.25 to ? 4.0 mm.

Authorization status:

A

Authorization date:

2023-06-20