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 Technology is designed to allow the stent graft to conform to anatomy reducing the risk of kinking and endoleaks
 

Flexibility

  • Ring body and helical limb structure incorporating halO Stent Technology,™ is designed to maintain patency in tortuous anatomies1
  • The circular design of the Aorfix Endovascular Stent Graft delivers unmatched flexibility while maintaining its luminal size — even in extreme angulations1

Flexibility

 halO Stent Technology allows Aorfix to have the flexibility to better match the anatomy in high neck angulations compared to traditional stent designs
 

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

Conformability

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

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 anatomy2
    • Aorfix is tested to 400 million pulses at 90° angulation
    • 5-7% pulsatility per 100mmHg - equivalent to 10 years
Durability
 
Aorfix 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°3&4

References:
3. 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.
 
4. 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.

Comparison of Aorfix 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 trial demonstrate Aorfix' 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 is designed to effectively exclude the aneurysm over 5 years with lasting seal even in the changing neck morphology
 
 
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.Demanget N, Duprey A, Badel P, Orgéas L, Avril S, Geindreau C, Albertini JN, Favre JP; 2013. Finite Element Analysis of the Mechanical Performances of 8 Marketed Aortic Stent-Grafts, J Endovasc Ther, 20:523–535.
2.Data held on file at Lombard Medical Inc.
3. 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.
4. 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.
5. AbuRahma AF, Campbell J, Stone PA, Nanjundappa A, Scott Dean L, Keiffer T, Emmett M. 2010. Early and late clinical outcomes of endovascular aneurysm repair in patients with an angulated neck. Vascular, 18(2), 93-101.
6. Torsello G, Troisi N, Donas KP, Austermann M. 2011. Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair. J Vasc Surg, 54(2), 300-6.
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