ANCHOR (Aneurysm Treatment Using the HeliFX Aortic Securement System Global Registry)

• Freedom from device related serious adverse events following the index procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Freedom from procedural related serious adverse events following index procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Subjects who meet inclusion/exclusion criteria and who are treated with the Aptus HeliFX Aortic Securement System in conjunction with commercially available non-Aptus Endografts will be divided, as appropriate, into two groups.

1. Primary Group- Subjects undergoing initial (primary) endovascular repair of an AAA where the investigator believes the proximal aortic neck is challenging such that the risk of failure or fixation and/or sealing is great enough so that the use of the HeliFX Aortic Securement System is warranted.
2. Revision Group- Those subjects who have previously undergone an EVAR procedure where the investigator believes that use of the EndoAnchor device is warranted to A- Treat existing graft migration and/or type 1a endoleak, with or without the concurrent use of other devices. B- Treat subjects believed to be at risk for migration and/or Type 1a endoleak Subjects must sign an IFC prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.

Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS recommendations.

Subjects undergoing primary placement of an approved endograft to treat an abdominal aortic aneurysm or subjects undergoing revision of a previously placed abdominal aortic endograft.

• Device: HeliFX Aortic Securement System
  Placement of the Aptus HeliFX™ Aortic Securement System in subjects with previously implanted commercial endografts, for the prevention of graft migration and the treatment of Type Ia endoleak or Aptus HeliFX Aortic Securement System placed at the time of initial endograft implantation, either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.
  Other Name: Endoanchors
• Procedure: AAA endograft placement
  Use of the Aptus HeliFX Aortic Securement System (EndoAnchors) during either primary placement or revision of a previously placed AAA endograft.
  Other Names:

  • Endoanchors
  • Endografts
  • AAA
  • Percutaneous Abdominal aortic Aneurysm repair
• Device: Use of Aptus HeliFX Aortic Securement System (EndoAnchors)
  Placement of Aptus EndoAnchors during revision of a previously placed AAA endograft
  Other Names:

  • Endoanchors
  • Endografts
  • AAA
  • Revision of AAA repair
  • Abdominal Aortic Aneurysm

• Primary Group
  Initial placement of an FDA approved AAA endograft with the concurrent use of HeliFX Aortic Securement System (EndoAnchors)
  Interventions:

  • Device: HeliFX Aortic Securement System
  • Procedure: AAA endograft placement
• Revision Group
  Revision of a previously placed non-Aptus AAA endograft wth the concurrent use of Aptus HeliFX Aortic Securement System (EndoAnchors)
  Interventions:

  • Device: HeliFX Aortic Securement System
  • Device: Use of Aptus HeliFX Aortic Securement System (EndoAnchors)

Inclusion Criteria:

• Subjects with asymptomatic, symptomatic, or ruptured abdominal aortic aneurysms
• Subject ≥ 18 years old
• Subject has provided written informed consent, either before or less than or equal to 30 days after the index procedure
• Subject is willing and able to comply with standard of care follow-up evaluations

• Subject has a previously implanted endograft (Revision Group), or will be undergoing repair (Primary Group), with one of the following abdominal aortic aneurysm endograft devices:

  • Cook Zenith
  • Gore Excluder
  • Medtronic AneuRx
  • Medtronic Talent
  • Medtronic Endurant
  • Any additional third party AAA endograft device that is commercially available and listed as compatible with the HeliFX system in the Instructions for Use
• Subject's iliac/femoral access is compatible a 16 French sheath
• Subject has a previously implanted endograft that has migrated or has a Type Ia endoleak (Revision Group) or will undergo implantation of an endograft that in the opinion of the Investigator will be at increased risk of such complications (Primary Group)

Exclusion Criteria:

• Subject has known allergy to the EndoAnchor implant material (nickel, chromium, molybdenum, or cobalt)
• Subject has a life expectancy less than 1 year
• Subject is participating in a clinical study or registry that, in the Investigator's opinion, may conflict or may have a negative impact on the subject's safety
• Subject has already been implanted with an EndoAnchor device in a procedure performed prior to the index procedure
• Subject has an active or known history of bleeding diathesis
• Subject has a condition that threatens to infect the endograft (active bacteremia, or infections that carry increased risk of endograft infection)
• Infrarenal aortic neck with significant thrombus or calcium that precludes adequate EndoAnchor penetration of the aortic wall
• Use where, for whatever reason, each EndoAnchor is not anticipated to adequately penetrate into the aortic wall.