GRAFTMASTER RX Coronary Stent Graft - Bare-metal coronary artery stent

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Abbott Vascular Division of Abbott Medical Australia Pty Ltd

Class:

Class III

Manufactured by:

Abbott Vascular 3200 Lakeside Drive, Santa Clara, CA, 95054 United States Of America

Therapeutic area:

53616 - Bare-metal coronary artery stent

Therapeutic indications:

Stent graft is made using sandwich technique with ultra thin layer of PTFE placed between two SS stents and pre-mounted on rapid exchange delivery system, with balloon and stent graft at distal end of catheter. Proximal end provides inflation of balloon with contrast. The central distal lumen permits guidewire insertion. Shaft of catheter, tip and taper of balloon are coated with hydrophilic coating. Two radiopaque markers mark working length of balloon and aid stent positioning. The GRAFTMASTER RX is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of Coronary Artery Aneurysm; Coronary Bypass-Vein Graft Aneurysm;Acute Coronary Artery Perforation and Acute Coronary Artery Rupture.

Authorization status:

A

Authorization date:

2013-09-05