BeGraft Aortic Stent Graft System - Multiple peripheral arteries stent

Intended purpose

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.

Functional description

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. Ø12 & 14mm can be maximally post-dilated with an appropriate balloon to 20mm, Ø16 & 18mm can be post-dilated to 24mm & Ø20 – 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.