Aortic Endovascular Repair Procedures

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Abdominal endovascular aneurysm repair (EVAR)

ESAR is a minimally invasive option for abdominal aortic aneurysm (AAA) repair.

Learn about EVAR

The standard for EVAR durability

Endurant^™ II/IIs AAA stent graft system

Design that uniquely addresses sac regression^1–4
First and only EVAR system with 10-year global registry data⁵ and outcomes protection program
Over half a million patients treated worldwide⁶

More on the Endurant™ systems

Indications, Safety, and WarningsNote: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details.IndicationsThe 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:

Adequate iliac or femoral access that is compatible with vascular access techniques, devices, or accessories

Proximal neck length of:

≥ 10 mm or
≥ 4 mm and < 10 mm when used in conjunction with the Heli-FX™ EndoAnchor™ system (bifurcated stent graft only)

Note: Neck length is defined as the length over which the aortic diameter remains within 10% of the infrarenal diameter.

Infrarenal neck angulation of ≤ 60°

Aortic neck diameters with a range of 19 to 32 mm

Distal fixation length(s) of ≥ 15 mm

Iliac diameters with a range of 8 to 25 mm

Morphology suitable for aneurysm repair

ContraindictionsThe Endurant™ II/Endurant™ IIs stent graft system is contraindicated in:

Patients who have a condition that threatens to infect the graft

Patients with known sensitivities or allergies to the device materials

When used with the Heli-FX™ EndoAnchor™ system, the Endurant™ II/IIs stent graft system is also contraindicated in:

Patients with known sensitivities to the EndoAnchor™ implant materials

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.Warnings and precautions

The long-term safety and effectiveness of the Endurant™ II/Endurant™ IIs stent graft system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft), or less than the recommended number of EndoAnchor™ implants when used in short proximal necks (≥ 4 mm and < 10 mm), should receive enhanced follow-up. Specific follow-up guidelines are described in the instructions for use.

Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures.

The Endurant™ II/Endurant™ IIs stent graft system is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation procedures as described in the instructions for use.

Renal complications may occur:

From an excess use of contrast agents
As a result of emboli or a misplaced stent graft. (The radiopaque marker along the edge of the stent graft should be aligned immediately below the lowermost renal arterial origin.)

Studies indicate that the danger of micro-embolization increases with increased procedure duration.

The safety and effectiveness of the Endurant™ II/Endurant™ IIs stent graft system has not been evaluated in some patient populations. Refer to the product instructions for use for details.

Adverse eventsPotential 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. 1HUC202505530 EN

Risks associated with EVAR procedures may include rupture, conversion to open repair, or secondary procedures.

Thoracic endovascular aortic repair (TEVAR)

TEVAR is a minimally invasive alternative to open surgery.

Learn about TEVAR

Deploy durability^7–10

Valiant^™ Captivia^™ thoracic stent graft system

Maintains continuous seal in a dynamic aortic environment⁷
Five-year outcomes in all DTA pathologies^8–10
More than 150,000 patients treated worldwide¹¹

More on Valiant™ Captivia™

Indications, Safety, and WarningsIndicationsThe Valiant™ thoracic stent graft with the Captivia™ delivery system is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having appropriate anatomy, including:

Iliac/femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories

Nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/penetrating ulcers), 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections)

Nonaneurysmal aortic proximal and distal neck lengths ≥ 20mm (fusiform and saccular aneurysms/penetrating ulcers), landing zone ≥ 20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections); proximal extent of the landing zone must not be dissected

ContraindicationsThe Valiant™ thoracic stent graft with the Captivia™ delivery system is contraindicated in:

Patients who have a condition that threatens to infect the graft

Patients with known sensitivities or allergies to the device materials

Warnings and precautionsThe long-term safety and effectiveness of the Valiant™ thoracic stent graft with the Captivia™ delivery system has not been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the integrity and performance of the implanted endovascular stent graft. Patients with specific clinical findings (for example, enlarging aneurysm (> 5 mm), endoleaks, migration, inadequate seal zone, or continued flow into the false lumen in the case of a dissection) should receive enhanced follow-up. Specific follow-up guidelines are described in the instructions for use. The Valiant™ thoracic stent graft with the Captivia™ delivery system is not recommended in patients who cannot undergo, or who will not be compliant with, the necessary preoperative and post-operative imaging and implantation procedures as described in the instructions for use. Strict adherence to the Valiant™ thoracic stent graft sizing guidelines as described in the instructions for use is expected when selecting the device size. Sizing outside of this range can potentially result in endoleak, fracture, migration, infolding, or graft wear. As cautioned in the instructions for use, a balloon should never be used when treating a dissection. The safety and effectiveness of the Valiant™ thoracic stent graft with the Captivia™ delivery system has not been evaluated in some patient populations. Refer to the product instructions for use for details.MRI safety and compatibility Non-clinical testing has demonstrated that the Valiant™ thoracic stent graft is MR Conditional. It can be scanned safely in both 1.5T and 3.0T MR systems under specific conditions as described in the product instructions for use. For additional information regarding MRI, refer to the product instructions for use.Adverse eventsPotential adverse events include, but are not limited to, access failure, access site complications (e.g., spasm, trauma, bleeding, rupture, dissection), adynamic ileus, allergic reaction (to contrast, antiplatelet therapy, stent graft material), amputation, anaesthetic complications, aortic expansion (e.g., aneurysm, false lumen), aneurysm rupture, angina, arrhythmia, arterial stenosis, atelectasis, blindness, bowel ischemia/infarction, bowel necrosis, bowel obstruction, branch vessel occlusion, buttock claudication, cardiac tamponade, catheter breakage, cerebrovascular accident (CVA)/stroke, change in mental status, coagulopathy, congestive heart failure, contrast toxicity, conversion to surgical repair, death, deployment difficulties/failures, dissection/perforation/rupture of the aortic vessel and/or surrounding vasculature, embolism, endoleak(s), excessive or inappropriate radiation exposure, extrusion/erosion, failure to deliver stent graft, femoral neuropathy, fistula (including aortobronchial, aortoenteric, aortoesophageal, arteriovenous, and lymph), gastrointestinal bleeding/complications, genitourinary complications, hematoma, hemorrhage/bleeding, hypotension/hypertension, infection or fever, insertion or removal difficulties, intercostal pain, intramural hematoma, leg/foot edema, lymphocele, myocardial infarction, neuropathy, occlusion — venous or arterial, pain/reaction at catheter insertion site, paralysis, paraparesis, paraplegia, paresthesia, perfusion of the false lumen, peripheral ischemia, peripheral nerve injury, pneumonia, post-implant syndrome, procedural/post-procedural bleeding, prosthesis dilatation/infection/rupture/thrombosis, pseudoaneurysm, pulmonary edema, pulmonary embolism, reaction to anaesthesia, renal failure, renal insufficiency, reoperation, respiratory depression/failure, sepsis, seroma, shock, spinal neurological deficit, stent graft material failure (including breakage of metal portion of device)/migration/misplacement/occlusion/twisting/kinking, transient ischemic attack (TIA), thrombosis, tissue necrosis, vascular ischemia, vascular trauma, wound dehiscence, wound healing complications, wound infection.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.

Risks associated with TEVAR procedures may include rupture, conversion to open repair, or secondary procedures.

EndoSuture aneurysm repair (ESAR)

ESAR mimics a sutured anastomosis to provide durability through reinforcement of the proximal seal in endovascular aneurysm repair (EVAR).^12,13

Learn about ESAR

Reinforced seal.^12,13 Redefined outcomes.^14–18

Heli-FX™ EndoAnchor™ system

Only commercially available device facilitating EndoSuture aneurysm repair (ESAR)¹⁹
Minimizes endoleaks and promotes greater sac regression^14,17,18
Durable five-year outcomes in challenging patient population¹⁴

More on Heli-FX™ system

Indications, Safety, and WarningsIndications for useThe Heli-FX™ EndoAnchor™ system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX™ EndoAnchor™ system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor™ implant may be implanted at the time of the initial endograft placement or during a secondary (i.e., repair) procedure.ContraindicationsTreatment with the Heli-FX™ EndoAnchor™ system is contraindicated for use in the following circumstances:

In patients with known allergies to the EndoAnchor™ implant material (MP35N-LT)

In conjunction with the Endologix Powerlink™* endograft

Warnings

The long-term performance of the EndoAnchor™ implant has not been established. All patients should be advised endovascular aneurysm treatment requires long-term, regular follow-up visits to assess the patient’s health status and endograft performance. The EndoAnchor™ implant does not reduce this requirement.

The EndoAnchor™ implant and the Heli-FX™ EndoAnchor™ system have been evaluated via in vitro testing and determined to be compatible with the Cook Zenith™*, Cook Zenith™* TX2™*, Gore Excluder™*, Gore TAG™*, Medtronic AneuRx™, Medtronic Endurant™, Medtronic Talent™ AAA, Medtronic Talent™ TAA, Medtronic Valiant™ Xcelerant™, Medtronic Valiant™ Captivia™, and Medtronic Valiant™ Navion™ endografts. Use with endografts other than those listed above has not been evaluated.

The performance of the EndoAnchor™ implant has not been evaluated for securing multiple endograft components together. Not securing EndoAnchor™ implants into aortic tissue could result in graft fabric damage, component separation, and resultant Type III endoleaks.

The performance of the EndoAnchor™ implant has not been evaluated in vessels other than the aorta. Use of the EndoAnchor™ implant to secure endografts to other vessels may result in adverse patient consequences such as vascular perforation, bleeding, or damage to adjacent structures.

The performance of the EndoAnchor™ implant has not been evaluated for securing multiple anatomical structures together. Such use could result in adverse patient consequences such as vascular perforation, bleeding, or embolic events.

Potential adverse eventsPossible adverse events that are associated with the Heli-FX™ EndoAnchor™ system include, but are not limited to:

Aneurysm rupture

Death

EndoAnchor™ implant embolization

Endoleaks (Type III)

Enteric fistula

Failure to correct/prevent Type I endoleak

Failure to prevent endograft migration

Infection

Renal complications (renal artery occlusion/dissection or contrast-induced acute kidney injury)

Stroke

Surgical conversion to open repair

Vascular access complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula

Vessel damage, including dissection, perforation, and spasm

Please reference product instructions for use for more information regarding indications, warnings, precautions, contraindications, and adverse events. Additional potential adverse events may be associated with endovascular aneurysm repair in general. Refer to the instructions for use provided with the endograft for additional potential adverse events.Caution: Federal law (United States) restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information.Caution: EndoAnchor™ implant locations should be based upon a detailed examination of the preoperative CT imaging in cases involving irregular or eccentric plaque in the intended sealing zones. EndoAnchor™ implants should be implanted only into areas of aortic tissue free of calcified plaque or thrombus, or where such pathology is diffuse and less than 2 mm in thickness. Attempting to place EndoAnchor™ implants into more severe plaque or thrombus may be associated with implantation difficulty and suboptimal endograft fixation and/or sealing. TM* Third party brands are trademarks of their respective owners.

Risks may include failure to prevent/correct type I endoleaks, migration, or sac enlargement.

Aortic endovascular repair procedures

Abdominal endovascular aneurysm repair (EVAR)

The standard for EVAR durability

Endurant^™ II/IIs AAA stent graft system

Thoracic endovascular aortic repair (TEVAR)

Deploy durability^7–10

Valiant^™ Captivia^™ thoracic stent graft system

EndoSuture aneurysm repair (ESAR)

Reinforced seal.^12,13 Redefined outcomes.^14–18

Heli-FX™ EndoAnchor™ system

Connect with us.

United States

Customer Care Team

Aortic endovascular repair procedures

Abdominal endovascular aneurysm repair (EVAR)

The standard for EVAR durability

Endurant™ II/IIs AAA stent graft system

Thoracic endovascular aortic repair (TEVAR)

Deploy durability7–10

Valiant™ Captivia™ thoracic stent graft system

EndoSuture aneurysm repair (ESAR)

Reinforced seal.12,13 Redefined outcomes.14–18

Heli-FX™ EndoAnchor™ system

Connect with us.

United States

Customer Care Team

Endurant^™ II/IIs AAA stent graft system

Deploy durability^7–10

Valiant^™ Captivia^™ thoracic stent graft system

Reinforced seal.^12,13 Redefined outcomes.^14–18