reengineering the art of evar - cordis...reengineering the art of evar ultra-low profile...

Reengineering the art of EVAR

Ultra-low profile

Customisable tri-modular design

Efficacy and durability without compromise1

Few units fit most anatomies


Reengineering the EVAR you know

Designed for PEVAR access Perform minimally invasive PEVAR

with the ultra-low-profile 13F inner and 14F outer diameter delivery system featuring an integrated sheath introducer and state-of-the-art device compression technology2*

Crafted for simplified navigation Highly flexible, hydrophilically coated catheter

helps minimise delivery-related complications by advancing smoothly through even the most tortuous, diseased, and heavily calcified vessels2

Engineered for ease of use Use conventional delivery techniques

and fewer procedural steps to perform your procedure in less time2

Without compromising durability, the INCRAFT® AAA Stent Graft System delivers the clinical efficacy you require, as demonstrated through 5 years in the INNOVATION Trial.*

*Based on CoreLab assessments demonstrated in the INNOVATION Trial.†Study protocol defined an increase in sac diameter as an increase of ≥5 mm.

** Pratesi G , Pratesi C, Chiesa R, Coppi G, Scheinert D, Brunkwall JS, Van der Meulen S, Torsello G. The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair. J Cardiovasc Surg (Torino). 2017 Oct;58(5):650-657

Case demonstration: Long-term clinical success through 4 years**

Pre-

Op

1 mon

th

6 m

onth

s

12 m

onth

s

24 m

onth

s

36 m

onth

s

48 m

onth

s

Mean AAA diameters at 1, 6, 12, and 60 months post-implantation1

Proven aneurysm reduction at 5 years1* 7.15 mm average sac diameter decrease 5 5% of patients show a decrease in sac size of ≥5mm at 5-year (22/49)

No sac increase observed (0/49)†


Ultra-low-profile delivery (13F inner and 14F outer diameter) to simplify access, navigation, and deployment.2

Customisable tri-modular design that leads to a tailored approach to EVAR.2

Efficacy and durability without compromise demonstrated through 2 years in the INNOVATION Trial.1

Few-fit-most concept requires fewer units to optimise procedure planning and inventory management.2

Talk to a Cordis representative about incorporating the INCRAFT

® AAA Stent Graft System into your EVAR programme.

Expect more from your AAA stent graft system

For healthcare professionals only. Important information: Prior to use, refer to the Instructions for Use supplied with this device for indications, contraindications, side effects, suggested procedure, warnings, and precautions.

As part of the Cordis policy of continuous product development, we reserve the right to change product specifications without prior notification.

The INCRAFT® AAA Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use.

Contact your Cordis sales representative for availability and ordering. All rights reserved. CORDIS, the Cordis LOGO, INCRAFT® are trademarks or registered trademarks of Cardinal Health. EU525-1 07/14 . © Cardinal Health 2017. All Rights Reserved.. CORDIS and INCRAFT are trademarks or registered trademarks of Cordis Corporation.

References: 1. Torsello G, Brunkwall J, Scheinert D. Cordis INCRAFT™ ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011;52(5):661-667. 2. Pratesi G. INCRAFT® AAA Stent Graft System 2-year clinical data from the INNOVATION Trial. Presented at: Charing Cross International Symposium. April, 2014. London, UK. 3. Chaikof EL, Fillinger MF, Matsumura JS. Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair. J Vasc Surg. 2002;35(5):1061-1066. 4. Kannan RY1, Salacinski HJ, Butler PE, et al. Current status of prosthetic bypass grafts: a review. J Biomed Mater Res B Appl Biomater. 2005;74(1):570-581.

20

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V I S I T Month 6 Month 12 Month 24 Month 36 Month 48 Month 60

From catheter to crown, the new ultra-low profile INCRAFT® System has been designed to enhance EVAR success—including your most complex cases.2

Constructed to help reduce procedure complexity

Innovative INCRAFT® System technology, including “cap-free” trans-renal design and peri-procedure customisation, enhances the capabilities of EVAR without adding complexity2

Treatment for a broader range of patients

Demonstrated in simple and complex anatomies including patients who would have been previously excluded from EVAR, even those with small (<7 mm), diseased, and challenging vessels2,3†

*15F inner and 16F outer diameter for the 34 mm aortic bifurcate.† Ensure that femoral access vessels are adequate and compatible with

vascular access techniques and accessories used with a 14F delivery profile.

Crafted to fit your needsWith custom deployment, optimised accuracy, and proven durability, you can free yourself from other device limitations and discover the benefits of the INCRAFT® AAA Stent Graft System.

Enduring modular junction strength Durable polymer-free sealing technology

helps reduce disconnection and type III endoleaks—interlocking suture knots on the limb graft connect to the Z-stents on the inside of the aortic bifurcate legs2

Accuracy assurance Optimised placement accuracy, proximally

and distally, from the perpendicularly deployed aortic bifurcate that, with the aid of distinctive radiopaque proximal markers, can be partially repositioned prior to full deployment

Enduring modular junction strength Durable polymer-free sealing technology

helps reduce disconnection and type III endoleaks—interlocking suture knots on the limb graft connect to the Z-stents on the inside of the aortic bifurcate legs2

Proven, biodurable fabric Seamlessly woven low-porosity polyester graft is kink-resistant to help mitigate perfusion of the AAA sac2,4

Enhanced stent-graft integrity Biocompatible laser-cut nitinol stents,

which combine radial force with stent fracture resistance, are sutured to the graft to minimise micro-motion2

Advanced graft stability Mitigate migration with the unique

suprarenal fixation mechanism, featuring a flared laser-cut, trans-renal stent and integrated sharpened barbs for robust wall anchoring2

Real-time customisation In-procedure bilateral in situ adjustments

(3 cm on ipsilateral and 2 cm on contralateral side) of limb prostheses substantially improve placement accuracy and reduce the risk of inadvertent side-branch coverage2

Few-fit-most surgical graft concept2

Fewer units designed for in-procedure customisation deliver broad anatomical coverage through a wide range (3–6 mm) of oversizing—allowing you to streamline preoperative planning and inventory management.

4 aortic bifurcate diameters 19 iliac limb diameter sizes

*As demonstrated in clinical trials.**1 patient developed a late graft occlusion at day 666 treated with thrombectomy and bypass.†1 death occurred within up to 1 year, 5 within the 2-year timeframe, all non-AAA related. All deaths were CEC adjudicated and confirmed to be unrelated

to the device or to the procedure. ‡2 patients underwent re-intervention for the correction of a Type I EL at day 61 and 278.

The art of EVAR stands the test of time

100%

80%

60%

40%

20%

0%

No compromise in the durability of the AAA repair at 5 years 2*

Freedom from type I

endoleaks

Freedom from fracture

Freedom from sac enlargement

Freedom from device/procedure-

related MAE

Stent graft patency

Freedom from type III

endoleaks

Freedom from migrations

Freedom from device/procedure related events : 100% (50/50)10

0%†

100%

†

100%

100%

100%

97%

100%

100%

100%

100%

100%

97%

97%

97%

**

1 YEAR

2 YEARS

5 YEARS

56/5

6

56/5

6

56/5

6

56/5

6

56/5

6

56/5

6

56/5

6

54/5

4

54/5

4

54/5

4

54/5

4

54/5

4

54/5

4

53/5

497

.4%

100%

92.1%

97.4

%

100%

100%

97.4

%

38/3

9

50/5

0

35/3

8

38/3

9

37/3

7

38/3

8

37/3

8








Without compromising durability, the INCRAFT® AAA Stent Graft System delivers the clinical efficacy you require, as demonstrated through 5 years in the INNOVATION Trial.*




Pre-

Op

1 mon

th

6 m

onth

s

12 m

onth

s

24 m

onth

s

36 m

onth

s

48 m

onth

s


Proven aneurysm reduction at 5 years1* 7.15 mm average sac diameter decrease 55% of patients show a decrease in sac size of ≥5mm at 5-year (22/49)







Talk to a Cordis representative about incorporating the INCRAFT

® AAA Stent Graft System into your EVAR programme.




The INCRAFT® AAA Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use.

Contact your Cordis sales representative for availability and ordering. All rights reserved. CORDIS, the Cordis LOGO, INCRAFT® are trademarks or registered trademarks of Cardinal Health. EU525-1 07/14 . © Cardinal Health 2017. All Rights Reserved.. CORDIS and INCRAFT are trademarks or registered trademarks of Cordis Corporation.


20

10

0

-10

-20

-30

DIA

ME

TE

R (

MM

)

V I S I T Month 6 Month 12 Month 24 Month 36 Month 48 Month 60








Without compromising durability, the INCRAFT®

AAA Stent Graft System delivers the clinical efficacy you require, as demonstrated through 5 years in the INNOVATION Trial.*




Pre-Op

1 month

6 months

12 months

24 months

36 months

48 months


Proven aneurysm reduction at 5 years1* 7.15 mm average sac diameter decrease 55% of patients show a decrease in sac size of ≥5mm at 5-year (22/49)







Talk to a Cordis representative about incorporating the INCRAFT® AAA Stent Graft System into your EVAR programme.




The INCRAFT® AAA Stent Graft System should only be used by physicians and teams trained in vascular interventional techniques, including training in the use of this device. Specific training expectations are described in the Instructions for Use. As part of its continuous product development policy, Cordis reserves the right to change product specifications without prior notification.

Contact your Cordis sales representative for availability and ordering. © Cardinal Health 2017. All Rights Reserved. CORDIS, the Cordis LOGO, and INCRAFT are trademarks of Cardinal Health and may be registered in the US and/or in other countries.100503409 10/17


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DIA

ME

TE

R (M

M)

VISIT Month 6 Month 12 Month 24 Month 36 Month 48 Month 60

Product Ordering Information

Order

For ordering information, please contact your Cordis representative.

Aort

ic B

ifur

cate

AB2298

AB2698

AB3098

AB3498

ProductCode

22

26

30

34

AB Size(mm)

17.0 – 19.9

20.0 – 22.9

23.0 – 26.9

27.0 – 31.0

TreatmentRange(mm)

13

13

13

15

DeliverySystem

ID (F)

14

14

14

16

DeliverySystemOD (F)

94

94

94

94

IpsiLength

(mm)

86

86

86

86

ContraLength

(mm)

Iliac

Lim

b /

Lim

b Ex

tens

ion

ProductCode

IL1008

IL1010

IL1012

IL1014

IL1308

IL1310

IL1312

IL1314

IL1608

IL1610

IL1612

IL1614

IL2008

IL2010

IL2012

IL2014

IL2410

IL2412

IL2414

IL Size(mm)

10

10

10

10

13

13

13

13

16

16

16

16

20

20

20

20

24

24

24

TreatmentRange(mm)

7.0 – 8.9

7.0 – 8.9

7.0 – 8.9

7.0 – 8.9

9.0 – 10.9

9.0 – 10.9

9.0 – 10.9

9.0 – 10.9

11.0 – 13.9

11.0 – 13.9

11.0 – 13.9

11.0 – 13.9

14.0 – 17.9

14.0 – 17.9

14.0 – 17.9

14.0 – 17.9

18.0 – 22.0

18.0 – 22.0

18.0 – 22.0

ILLength

(mm)

82

101

120

138

82

101

120

138

82

101

120

138

82

101

120

138

101

120

138

DeliverySystemOD (F)

12

12

12

12

12

12

12

12

12

12

12

12

12

12

12

12

13

13

13

IpsiLength

(mm)

128 – 156

147 – 175

166 – 194

184 – 212

128 – 156

147 – 175

166 – 194

184 – 212

128 – 156

147 – 175

166 – 194

184 – 212

128 – 156

147 – 175

166 – 194

184 – 212

147 – 175

166 – 194

184 – 212

ContraLength

(mm)

128 – 147

147 – 166

166 – 185

184 – 203

128 – 147

147 – 166

166 – 185

184 – 203

128 – 147

147 – 166

166 – 185

184 – 203

128 – 147

147 – 166

166 – 185

184 – 203

147 – 166

166 – 185

184 – 203

Product Portfolio

Order

Aort

ic E

xten

sion

AE2204AE2604AE3004

AE3404

Product Code

222630

34

Aortic Extension

Diameter (mm)

17.0 – 19.920.0 – 22.923.0 – 26.9

27.0 – 31.0

Treatment Range(mm)

131313

15

Delivery System

ID (F)

141414

16

Delivery System OD (F)

424242

42

Length(mm)

reengineering the art of evar - cordis...reengineering the art of evar ultra-low profile...

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