Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF 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 guidance.
⁃ Subjects with asymptomatic, symptomatic, or ruptured aortic aneurysms
⁃ Subject ≥ 18 years old
⁃ Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
⁃ Subject is willing and able to comply with standard of care followup evaluations
⁃ Subject has a previously implanted endograft or will be undergoing repair, with one of the following aortic aneurysm endograft devices:
∙ Cook Zenith or Cook Zenith TX2
‣ Gore Excluder or TAG
‣ Medtronic AneuRx
‣ Medtronic Talent
‣ Medtronic Endurant or Valiant
‣ Any additional third party AAA endograft device that is commercially available and listed as compatible with Heli-FX™ in the IFU
⁃ Subject's iliac/femoral access is compatible with:
∙ a 16 French sheath (abdominal subjects)
‣ 18 French sheath (thoracic subjects)
‣ Selected 16 or 18 French sheath, as applicable to the device selected for use (advanced disease subjects)
⁃ Subject has a previously implanted endograft that has migrated or has a Type I endoleak within the aorta or will undergo implantation of an endograft that in the opinion of the investigator will be at increased risk of such complications
• Subjects with asymptomatic or symptomatic abdominal aortic aneurysms that will receive the Heli-FX™ in conjunction with the Endurant II/IIs endograft as part of their planned EVAR treatment
• Subject ≥ 18 years old
• Subject has provided written informed consent, either before or less than or equal to 30 calendar days after the index procedure
• Subject is willing and able to comply with standard of care followup evaluations
• Subject will be undergoing AAA repair with the bifurcated main body Endurant II/IIs stent graft in conjunction with Heli-FX™ with a proximal neck length of ≥ 4mm to \< 10mm and treated in accordance with the Endurant II/IIs and Heli-FX™ IFUs
• Subject's iliac/femoral access is compatible with a 16 French sheath