Bentley Innomed BeGraft Aortic Stent Graft System - HSA Registration DE0501598
Access comprehensive regulatory information for Bentley Innomed BeGraft Aortic Stent Graft System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0501598 and owned by Bentley InnoMed GmbH. The device was registered on May 03, 2018.
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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.