INCRAFT AAA Stent-Graft System - Abdominal aortic aneurysm stent

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Cordis Australia Pty Ltd

Class:

Class III

Manufactured by:

Cordis Cashel Cahir Road, Cashel, Co Tipperary Ireland

Therapeutic area:

46777 - Abdominal aortic aneurysm stent

Therapeutic indications:

The prostheses is loaded onto a delivery system component. The delivery system facilitates precise placement of the prosthesis into the vasculature via fluoroscopy. Following deployment of the prosthesis, its exposure to blood at body temperature causes the stents to self-expand to their pre-set diameters. Intended for the endovascular treatment of patients with infrarenal abdominal aortic aneurysms with the following characteristics: Femoral access vessels should be adequate to fir the selected delivery system,proximal neck length greater or equal to 10mm, aortic neck diameters greater or equal to 17mm and less than or equal to 31mm, aortic neck suitable for suprarenal fization, infrarenal and suprarenal neck angulation less than or equal to 60 degrees, illiac fixation length geeater than or equal to 15mm, illiac diameters greater or equal to 7 mm and less than or equal to 22mm, minimum overall AAA treatment length (proximal landing location to distal landing location) greater than or equal to 128mm, morphology suitable for aneurysm repair.

Authorization status:

A

Authorization date:

2014-12-16