Stent Graft System
- UID
- IMP/MD/2019/000466_4e1501c99ce27b28129b025c3e7fdcf9_58a93b8c9dd1b8e78ed7ccfa8c3c7c08
- Device class
- Class D
- Brand name
- BeGraft Aortic
- License holder
- Vibgyor Health Care Pvt. Ltd.
- Approving authority
- CDSCO
- 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.
Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000466_4e1501c99ce27b28129b025c3e7fdcf9_58a93b8c9dd1b8e78ed7ccfa8c3c7c08. This device is marketed under the brand name BeGraft Aortic. The license holder is Vibgyor Health Care Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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