Endovascular Stent with a Coating - Vietnam Registration 2403355ĐKLH/BYT-HTTB

The Radiant vascular stent graft is designed to maintain blood flow to the renal arteries when used in combination with the Endurant II/IIs abdominal aortic stent graft. These devices are used together to treat the condition of aneurysm of the common iliac artery or an aneurysm of the abdominal aorta adjacent to the kidney by the technique of parallel grafting, an endovascular procedure. The procedure involves creating a bypass to divert the blood flow in the patient's blood vessels (the abdominal aorta, the common iliac arteries, and the renal arteries) by the method of sac exclusion (the target lesion). Indications: The Radiant vascular stent graft is indicated to maintain blood flow to the renal arteries when used in combination with the Endovascular Support System Endurant II/IIs in the treatment of an aneurysm of the common iliac artery or an aneurysm of the abdominal aorta adjacent to the kidney by the technique of parallel grafting in patients with the following characteristics: • Morphology suitable for the endovascular treatment of the aneurysm • One of the following characteristics: – The diameter of the aneurysm >5 cm – The diameter of the aneurysm from 4 to 5 cm, with an increase of 0.5 cm over the past 6 months – The aneurysm is at least 1.5 times the diameter of the normal renal artery below the kidney • The diameter of the common iliac artery from 19 to 30 mm • The length of the proximal neck below the kidney ≥2 mm and the total length of the covered portion at the proximal neck >15 mm when the Radiant vascular stent graft is deployed in parallel grafting technique in one or both renal arteries and there is minimal calcification or thrombosis with the angle between the suprarenal aorta and the renal artery ≤45°, the infrarenal aorta ≤60°, and the suprarenal aorta ≤45°, and the diameter of the abdominal aorta is less than 20% to 30% smaller than the diameter of the Endovascular Support System Endurant II/IIs as specified in the product label • The approach to the femoral or brachial artery is suitable for the technique, device, or vascular access accessories • Sufficient length of the renal region fixation • The angle of origin of the renal artery <90° relative to the aortic axis Note: The angle between the aortic axis and the renal artery is the angle of origin of the renal artery. An angle <90° is associated with a downward orientation of the renal artery relative to the aortic axis.