Bentley Innomed BeGraft Aortic Stent Graft System

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

VASCUASIA PTE. LTD.

Class:

Class D medical device

Manufactured by:

Bentley InnoMed GmbH

Therapeutic area:

Cardiovascular

Therapeutic indications:

BeGraft Aortic Stent Graft System is indicated for • implantation in native & or recurrent coarctation of the aorta (CoA*) on adolescent/adult patients with the following:Stenosis of aorta resulting in significant anatomic narrowing as determined by angiography/noninvasive imaging, i.e. echocardiography,magnetic resonance imaging (MRI), CT scan; Stenosis of aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function;Stenosis of aorta where balloon angioplasty is ineffective/contraindicated;Stenosis diameter <20% of the adjacent vessel diameter.Stenosis that would present increased risk of vascular damage of disruption. • And furthermore for restoring & improving the patency of the iliac arteries**. *) Sizes approved for CoA: Ø12-16mm in lengths of 19-49mm, Ø18+20mm in lengths of 28–48mm, Ø22+24mm in lengths of 37+48mm. **) Sizes approved for iliac arteries: Ø12-16mm in lengths of 28–59mm.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Sterile by EO; Models: BeGraft Aortic Stent Graft System - BGA1912_1, BeGraft Aortic Stent Graft System - BGA1912_2, BeGraft Aortic Stent Graft System - BGA2912_1, BeGraft Aortic Stent Graft System - BGA2912_2, BeGraft Aortic Stent Graft System - BGA3912_1, BeGraft Aortic Stent Graft System - BGA3912_2, BeGraft Aortic Stent Graft System - BGA4912_1, BeGraft Aortic Stent Graft System - BGA4912_2, BeGraft Aortic Stent Graft System - BGA5912_1, BeGraft Aortic Stent Graft System - BGA5912_2, BeGraft Aortic Stent Graft System - BGA1914_1, BeGraft Aortic Stent Graft System - BGA1914_2, BeGraft Aortic Stent Graft System - BGA2914_1, BeGraft Aortic Stent Graft System - BGA2914_2, BeGraft Aortic Stent Graft System - BGA3914_1, BeGraft Aortic Stent Graft System - BGA3914_2, BeGraft Aortic Stent Graft System - BGA4914_1, BeGraft Aortic Stent Graft System - BGA4914_2, BeGraft Aortic Stent Graft System - BGA5914_1, BeGraft Aortic Stent Graft System - BGA5914_2, BeGraft Aortic Stent Graft System - BGA1916_1, BeGraft Aortic Stent Graft System - BGA1916_2, BeGraft Aortic Stent Graft System - BGA2916_1, BeGraft Aortic Stent Graft System - BGA2916_2, BeGraft Aortic Stent Graft System - BGA3816_1, BeGraft Aortic Stent Graft System - BGA3816_2, BeGraft Aortic Stent Graft System - BGA4816_1, BeGraft Aortic Stent Graft System - BGA4816_2, BeGraft Aortic Stent Graft System - BGA5816_1, BeGraft Aortic Stent Graft System - BGA5816_2, BeGraft Aortic Stent Graft System - BGA2918_2, BeGraft Aortic Stent Graft System - BGA3818_2, BeGraft Aortic Stent Graft System - BGA4818_2, BeGraft Aortic Stent Graft System - BGA2720_2, BeGraft Aortic Stent Graft System - BGA3720_2, BeGraft Aortic Stent Graft System - BGA4820_2, BeGraft Aortic Stent Graft System - BGA3722_2, BeGraft Aortic Stent Graft System - BGA4822_2, BeGraft Aortic Stent Graft System - BGA3724_2, BeGraft Aortic Stent Graft System - BGA4824_2

Authorization date:

2018-05-03