Aorfix™ - EVAR

Unique Design. Proven Indication

Unique Design


  • Intelligent engineering expands the physicians’ reach to treat a wider range of anatomies with EVAR
  • Revolutionary technology combines circular and helical structures that provide the flexibility needed to treat tortuous of anatomies

halO Stent TechnologyTM is designed to allow the stent graft to conform to anatomy reducing the risk of kinking and endoleaks.

            Aorfix - intelligent engineering

Aorfix halo stent technology

Flexibility

  • Ring body and helical limb structure incorporating halO Stent TechnologyTM, is designed to maintain patency in tortuous anatomies
  • The circular design of the AorfixTM Endovascular Stent Graft delivers unmatched flexibility while maintaining its luminal size — even in extreme angulations

halO Stent TechnologyTM allows AorfixTM to have the flexibility to better match the anatomy in high neck angulations compared to traditional stent designs.

Aorfix Z stent design

Conformability

Designed to adapt to changing anatomy over time and accommodate pulsatile forces
Unique fish-mouth design facilitates a superior seal in changing neck morphologies.

Traditional stent graft designs versus halO Stent TechnologyTM which is engineered to conform to anatomical changes over time.


Aorfix conformability

Durability

  • Self-expanding electropolished nitinol wires mould to uneven vessel walls for improved apposition and seal
  • Rigorous testing performed that simulates in situ movement in angulated anatomy1
    • AorfixTM is tested to 380 million cycles at 90° angulation - equivalent to 10 years
    • 5-7% pulsatility per 100mmHg 

Aorfix durability

AorfixTM Endovascular Stent Graft

 AorfixTM Endovascular Stent Graft is designed to mould to tortuous arterial anatomies as well as maintain strong links between joining limb extensions

Proven Indication

The Aorfix™ Endovascular Stent Graft is designed to extend the proven performance of current EVAR devices to include the successful treatment of complex anatomies with neck angulations of 0° to 90° as well as tortuous iliac arteries.

A direct comparison of the PYTHAGORAS IDE data with various competitor IDE data shows the strength of the Aorfix™ clinical outcomes, results are unimpeded by the inclusion of patients with more challenging neck angulations significantly greater than 60. 2,3

Comparison of AorfixTM Results Versus Competitors

Proper graft fit and seal ensure procedural success and longevity in the treatment of neck angulations or tortuous iliacs. The results of the PYTHAGORAS trial4 demonstrate AorfixTM ability to achieve aims across a wider range of anatomies than competitive devices, due to Aorfix's unique flexible, conformable and durable design.




5 Year Follow Up

Aorfix 5 year follow up

AorfixTM, is designed to effectively exclude the aneurysm over 5 years with lasting seal even in the changing neck morphology

Aorfix 5 year follow up post op

Impressive sac diameter reduction over time with complete patency in the iliac arteries Images courtesy of Dr. Gregory Schultz, Sanford Health, Sioux Falls, SD


  1. Data held on file by Lombard Medical Limited - Study SP413 and/or BS EN ISO 25539-1
  2. Hobo R, Kievit J, Leurs LJ, Buth J; EUROSTAR Collaborators. 2007. Influence of severe infrarenal aortic neck angulation on complications at the proximal neck following endovascular AAA repair: a EUROSTAR study. J Endovasc Ther, 14(1), 1-11.
  3. Choke E, Munneke G, Morgan R, Belli AM, Loftus I, McFarland R, et al. 2006. Outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile neck anatomy. Cardiovasc Intervent Radiol, 29(6), 975-80.
  4. Malas M, Hicks CW, Jordan Jr WD, Hodgson KJ, et al. 2017. Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks. JoVS,  65(6), 1598-1607

Evidence Backed Performance

The AorfixTM Endovascular Stent Graft and Delivery System was CE-Approved in 2001.
The AorfixTM Endovascular Stent Graft is not available for use in the USA.

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