Stent Graft System - India CDSCO Medical Device Registration

Product Information

The “BeGraft Aortic Stent Graft System” is indicated for • the implantation in the native and/or recurrent coarctation of the aorta (BeGraft Aortic) on adolescent or adult patients with the following clinical conditions: - Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging, i.e. echocardiography, magnetic resonance imaging (BeGraft Aortic), 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 further more for restoring and improving the patency of the iliac arteries**. *) Sizes approved for CoA: Ø 12 -16 mm in lengths of 19 - 49 mm, Ø 18 and 20 mm in lengths of 27 - 48 mm and Ø 22 and 24 mm in lengths of 37 and 48 mm. **) Sizes approved for iliac arteries: Ø 12 - 16 mm in lengths of 29 - 59 mm.