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

البلد: أستراليا

اللغة: الإنجليزية

المصدر: Department of Health (Therapeutic Goods Administration)

متاح من:

Microport Crm Pty Ltd

الفئة:

Class III

المصنعة من قبل:

Shanghai MicroPort Medical Group Co Ltd 501 Newton Road, ZJ Hi-Tech Park, Shanghai, 201203 China

المجال العلاجي:

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

الخصائص العلاجية:

The product is a balloon expandable stent with grooves on the outer surface of stent struts. The grooves are coated with a biodegradable drug (rapamycin)/polymer(DL-PLA) matrix. The delivery system is a rapid exchange (RX) balloon catheter with effective working length of 140 cm. The Firehawk 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.

الوضع إذن:

A

تاريخ الترخيص:

2021-12-24