Stent Graft System - India CDSCO Medical Device Registration

Product Information

The AnkuraTM Stent Graft Systems are indicated for the endovascular repair of patients with aortic and aorto-iliac diseases having morphology suitable for endovascular repair. The AnkuraTM TAA Stent Graft System is indicated for endovascular repair of patients with thoracic aortic aneurysms or thoracic aortic dissection, requiring: 1) Adequate iliac/femoral access vessel that is compatible with the required delivery system. 2) Aortic inner diameter in the range of 18-42mm. 3) ≥15mm non-aneurysmal aorta proximal and distal to the lesion. 4) Morphology suitable for endovascular repair. Type B dissections in patients who have appropriate anatomy,induding; 1) Adequate iliac/femoral access vessel that is compatible with the required delivery system. 2）≥15mm landing zone proximal to the primary entry tear;proximal extent of the landing zone must not be dissected. Diameter at proximal extent of proximal landing zone in the range of 16-44mm. 3）≥15mm landing zone distal to the primary entry tear; distal extent of the landing zone must not be dissected. Diameter at distal extent of distal landing zone in the range of 16-44mm. 4）Morphology suitable for endovascular repair. The AnkuraTM AAA Stent Graft and cuff Stent Graft consisted of a modular system, which is indicated for endovascular repair of patients with abdominal aortic aneurysms, requiring: 1）adequate iliac/femoral access compatible with the required delivery system; 2）non-aneurysmal proximal aortic neck length ≥15mm; 3）proximal aortic neck angulation ≤ 60°; 4）distal iliac artery anchorage zone ≥15mm; 5）distal iliac artery diameter of 8-22mm; 6）morphology suitable for endovascular repair. The AnkuraTM AUI Stent Graft System is indicated for endovascular repair of patients with abdominal aortic aneurysms, requiring: 1）adequate iliac/femoral access compatible with the required delivery system; 2）non-aneurysmal proximal aortic neck length ≥15mm; 3）non-aneurysmal proximal aortic neck diameter of 18-32mm; 4）proximal aortic neck angulation ≤ 60°; 5）distal iliac artery anchorage zone ≥15mm; 6）distal iliac artery diameter of 10-16 mm; 7）morphology suitable for endovascular repair