Safety Information | 合法醫療器材資訊網

TheOvationAbdominalStentGraftSystemisforsinglepatientuseonly.Donotreuse,reprocessorre-sterilize.Reuse,reprocessingorre-sterilizationmay ...

AFX2 Endovascular AAA System

INDICATIONS FOR USE (US):The Endologix® AFX®2 Endovascular AAA System is indicated for endovascular treatment in patients with AAA using a surgical vascular access technique or a bilateral percutaneous technique. The devices are indicated for patients with suitable aneurysm morphology for endovascular repair, including: Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥ 6.5 mm); Non-aneurysmal aortic neck between the renal arteries and the aneurysm: with a length of ≥ 15 mm; with a diameter of ≥ 18 mm and ≤ 32 mm; with a neck angle of ≤ 60° to the body of the aneurysm. Aortic length ≥ 1.0 cm longer than the body portion of the chosen bifurcated model. Common iliac artery distal fixation site: with a distal fixation length of ≥ 15 mm; with ability to preserve at least one hypogastric artery; with a diameter of ≥ 10 mm and ≤ 23 mm; with...