BeGraft Aortic Stent Graft System - Multiple peripheral arteries stent

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

זמין מ:

Device Technologies Australia Pty Ltd

סיווג:

Class III

תוצרת:

Bentley InnoMed GmbH Lotzenacker 3, Hechingen, 72379 Germany

איזור תרפויטי:

47932 - Multiple peripheral arteries stent

סממני תרפויטית:

A balloon-expandable CoCr stent, covered with ePTFE graft material, pre-mounted on the balloon of an over the wire (OTW) Delivery System. Available in 3 stent designs. ?12 & 14mm can be maximally post-dilated with an appropriate balloon to 20mm, ?16 & 18mm can be post-dilated to 24mm & ?20 ? 24mm can be post-dilated to 30mm. Compatible with 0.035? (0.89mm) guide wires. Two radiopaque markers located underneath the balloon fluoroscopically identify the position of the stent on the balloon. The ?BeGraft Aortic Stent Graft System? is indicated for; ? the implantation in the native and/or recurrent coarctation of the aorta (CoA) on adolescent or adult patients with the following clinical conditions: -- Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or noninvasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT scan; -- Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function; -- Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated; -- Stenosis diameter <20% of the adjacent vessel diameter. Stenosis that would present increased risk of vascular damage of disruption. ? and furthermore for restoring and improving the patency of the iliac arteries.

מצב אישור:

A

תאריך אישור:

2017-02-22