Endurant™ stent graft system is designed to treat abdominal aortic aneurysms (AAA) using a minimally invasive endovascular aneurysm repair (EVAR).
Note: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details.
The Endurant™ II/Endurant™ IIs bifurcated stent grafts are indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. They may be used in conjunction with the Heli-FX™ EndoAnchor™ system when augmented radial fixation and/or sealing is required; in particular, in the treatment of abdominal aortic aneurysms with short (≥ 4 mm and < 10 mm) infrarenal necks (see neck length definition below). The Endurant™ II stent graft system aorto-uni-iliac (AUI) stent graft is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms in patients whose anatomy does not allow the use of a bifurcated stent graft. The Endurant™ II/IIs stent graft system is indicated for use in patients with the following characteristics:
The Endurant™ II/Endurant™ IIs stent graft system is contraindicated in:
When used with the Heli-FX™ EndoAnchor™ system, the Endurant™ II/IIs stent graft system is also contraindicated in:
For contraindications regarding ancillary devices used with the Endurant™ II/Endurant™ IIs stent graft system, refer to the instructions for use provided with the device.
Potential adverse events include (arranged in alphabetical order): amputation; anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement; aneurysm rupture and death; aortic damage, including perforation, dissection, bleeding, rupture, and death; arterial or venous thrombosis and/or pseudoaneurysm; arteriovenous fistula; bleeding, hematoma, or coagulopathy; bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); claudication (e.g., buttock, lower limb); death; edema; EndoAnchor™ system (for infrarenal EVAR procedures using the Heli-FX™ EndoAnchor™ system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage; embolization (micro and macro) with transient or permanent ischemia or infarction; endoleak; fever and localized inflammation; genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, femoral-femoral artery thrombosis, fistula, incontinence, hematuria, infection); hepatic failure; impotence; infection of the aneurysm, device access site, including abscess formation, transient fever, and pain; lymphatic complications and subsequent attendant problems (e.g., lymph fistula); neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); occlusion of device or native vessel; pulmonary complications and subsequent attendant problems; renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; surgical conversion to open repair; vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); vessel damage; wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis).
Please reference product instructions for use for more information regarding indications, warnings, precautions, contraindications, and adverse events.
Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.
FTSOP113326-06 Rev. 1H
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Nonclinical testing has demonstrated that the Endurant™ II/Endurant™ IIs stent graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under certain conditions as described in the product instructions for use. For additional MRI safety information, refer to the product instructions for use.
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Find more information, including other available configurations, for Endurant™ II and Endurant™ IIs stent graft system.
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