Designed, tested, FDA approved and proven to perform in all angles up to 90˚

Pre-Operative Post-Operative 2 year

Ref:

120-

210

0-90º

The 1st and only AAA stent graft approved by the FDA for use with 0 – 90̊ angles

Why compromise? Choose AORFIX™

for all neck angulations from 0 –̊90˚

1. AbuRahma, A. F., Campbell, J., Stone, P. A., 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. 2. Bench test data on file.

Secure fixation 8 cat’s claw hooks placed at the proximal edge of 4 closely spaced stent rings that cover 8mm in the proximal seal zone

Supreme flexibility in neck angles up to 90° with ring stent structure

Effective sealing Aorfix™ shown to reduce type 1 endoleaks in high angulations¹

Highly flexible limbs

Positioning Tantalum radiopaque markers aid positioning²

Interlocking modular connections minimize dislocations

Inter-locking helical design

SIZING COMPONENT GUIDE

1. Refer to product specific IFUs for full indications. For further details please refer to the Aorfix™ IFU. 2. Aorfix™ US IDE trial results, see Aorfix™ IFU for full details. 3. Competitor data from Summaries of Safety and Effectiveness filed with FDA. SSE Ref: Aorfix™: P110032 Feb 14, 2013. Talent: P070027 April 15, 2008. Endurant: P100021 Dec 16, 2010. EndoLogix: P040002 Oct 29, 2004. Excluder: P020004 Nov 6, 2002. Zenith: P020018 May 23, 2003. Zenith Hi Risk: P020018 May 23, 2003.

• Only Pythagoras low angle data <60° can be compared with competitors’ FDA results as there are no other high angle FDA trials.

• Aorfix™ demonstrates better or comparable performance and results when compared with competitor AAA stent grafts in angulation <60°.

UnrivAlleD clinicAl PerFOrmAnce bAseD On eviDence²

AOrFix™ resUlts vs Other AAA stent grAFts ³

Overall Pythagoras results

Freedom from SVS MAE (30 d)

Mortality (30 d)

Mortality (1 yr)

Sac shrinkage (5mm 1yr)

Sac expansion (5mm 1yr)

Type I/III leak (1yr)

Migration (10mm 1yr)

Aorfix™ Aorfix™ Aorfix™<60° 60-133° All SVS control groupN=67 N=151 N=218 N=323

92.5% 81.5% 84.9% 56.4%

1.5% 2.0% 1.8% 2.8%

4.5% 7.9% 6.9% 6.5%

36.7% 44.1% 41.9% •

0% 1.8% 1.2% •

0% 1.9% 1.3% •

0% 1.7% 1.2% •

Performance of Aorfix™ reduces only slightly in angles from 60° to 90°

UniqUe inDicAtiOn

0º – 60º 60º – 90º

Comparison of IFU indications for neck angulations1

AAA stent graft

Aorfix™ 3 3

Endurant 3 7

Zenith 3 7

Excluder 3 7

Freedom from SVS MAE (30 d)

Mortality (30 d)

Mortality (1 yr)

Sac shrinkage (5mm 1yr)

Sac expansion (5mm 1yr)

Type I/III leak (1yr)

Migration (10mm 1yr)

%

Different definitions used, not

comparable

Aorfix™

<60° Talent Endurant Endologix Gore Cook Cook N=67 Excluder Zenith Zenith (Hi Risk)

92.5% 96% 89%

1.5% 1.8% 0% 1% 1.3% 0.5% 2%

4.5% 6.5% 4% 6.8% 7.2% 3.5% 9%

36.7% 33.6 % 49.6% 35.7% 14.3% 67.5% 62.9%

0% 2.3% 0% 2% 7.1% 1.3% 1.6%

0% 2.5% 0% 0% 1.3% 1.4% 1.8%

0% 0.8% 0% 0.7% 2.3% 2.5% 2.8%

Different definitions used, not

comparable

Different definitions used, not

comparable

Different definitions used, not

comparable

1 year

For further details please refer to the Aorfix™ AAA Flexible Stent Graft System IFU.

Revised Stent Brochure concertina stg9.indd 1-3 05/06/2013 19:36

AORFIX™ – the only AAA stent graft approved for all angulations from 0 – 90̊ , now even easier to use with AORFLEX™ Delivery Device

Enhanced control for effective deployment, specifically for AAA patients with complex anatomies

The confident choice for all angles 0 –̊90˚ NEW AOrFlex™ Delivery Device

Sheath control allows controlled step-by-step fishmouth and graft body deployment

Reduced blood loss with improved valve performance*

Support tube release disconnects Aorfix™ stent graft from the delivery device

Seam orientation marker aids correct orientation prior to insertion

Proximal handle for delivery system stabilization

Initial 10 cm of sheath free of hydrophilic coating for improved grip

Distal stop

No hydrophilic coating

Enhanced navigation in tortuous anatomy*

Improved maneuvering and reduced friction between the delivery device and vessel walls

greater deployment control with reduced deployment forces*

Excellent torque, pushabililty and trackability

High kink resistance and flexibility

Reduced risk of sheath stretch in complex anatomies

confidence with precise positioning*

Platinum Iridium radiopaque marker with excellent radiopacity

Indicates accurate position of the sheath during deployment

Excellent angiographic visibility

Excellent torque and kink resistance

Gentle taper for trackability in tortuous vessels

Reduced friction and enhanced navigation with hydrophilic coating*

Optimal flexibility with interlocking spine

The ONLY

ONE APPROVED by FDAin neck angles UP TO

90º

AORFIX™ AAA Flexible Stent Graft System

*Compared with performance of Aorfix™ generation 2 delivery system used in the Pythagoras PMA Study. Data on file at Lombard Medical.

Revised Stent Brochure concertina stg9.indd 4-6 05/06/2013 19:37