W. L. Gore & Associates, Inc.Flagstaff, AZ 86004

+65.67332882 (Asia Pacific) 800.437.8181 (United States)00800.6334.4673 (Europe) 928.779.2771 (United States)

goremedical.com

Products listed may not be available in all markets. CBAS is a trademark of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.GORE®, PROPATEN®, and designs are trademarks of W. L. Gore & Associates, Inc.© 2014, 2019 W. L. Gore & Associates, Inc. AT0375-EN2 JUNE 2019

GORE® PROPATEN® Vascular GraftProven patency. Measurable value.

Features Gore’s CBAS Heparin Surface, the proven heparin bonding technology for lasting thromboresistance, used in many of Gore’s interventional and vascular surgery products. End-point covalent bonding keeps heparin anchored to the graft surface, while the bioactive site remains free to interact with the blood to help prevent clotting.7

References

1. Begovac PC, Thomson RC, Fisher JL, Hughson A, Gällhagen A. Improvements in GORE-TEX® Vascular Graft performance by Carmeda® BioActive Surface heparin immobilization. European Journal of Vascular & Endovascular Surgery 2003;25(5):432-437.

2. Lindholt JS, Gottschalksen B, Johannesen N, et al. The Scandinavian PROPATEN® Trial – 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses – a randomized clinical controlled multi-centre trial. European Journal of Vascular & Endovascular Surgery 2011;41(5):668-673.

3. GORE® PROPATEN® Vascular Graft. W. L. Gore & Associates Web site. https://www.goremedical.com/propaten/references. Accessed May 15, 2019.

4. Gore S, Andersson J, Biran R, Underwood C, Riesenfeld J. Heparin surfaces: impact of immobilization chemistry on hemocompatibility and protein adsorption. Journal of Biomedical Materials Research Part B: Applied Biomaterials 2014;102(8):1817-1824.

5. Freeman J, Chen A, Weinberg RJ, Okada T, Chen C, Lin PH. Sustained thromboresistant bioactivity with reduced intimal hyperplasia of heparin-bonded PTFE Propaten Graft in a chronic canine femoral artery bypass model. Annals of Vascular Surgery 2018;49:295-303.

6. Biran R, Pond D. Heparin coatings for improving blood compatibility of medical devices. Advanced Drug Delivery Reviews 2017;112:12-23.

7. CBAS Heparin Surface. W. L. Gore & Associates Web site. https://www.goremedical.com/cbas/references. Accessed May 3, 2019.

8. Biran R. Heparin Activity and Concentration Values from 52 and 96 Month Duration Clinical Explants of the GORE® PROPATEN® Vascular Graft. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2011. [Work plan]. WP104647.

84%N=860

74%N=445

58%N=360

79%N=606

68%N=445

58%N=360

76%N=520

60%N=360 58%

N=360

75%N=971

46%N=693

65%N=782

51%N=120

56%N=703

* Overall weighted average primary patency is based on data from 15 peer-reviewed publications meeting pre-determined inclusion criteria. Visit propatenperformance.com to see inclusion criteria, explore the data, and see publications.

** Data not reported.

Study size (N) reflects the initial cohort size of the study.

Strength of leadershipGORE® PROPATEN® Vascular Graft Above-knee bypass primary patency

GORE® PROPATEN® Vascular Graft Below-knee bypass primary patency

1 year*

1 year*

2 years*

2 years*

3 years*

3 years*

4 years*

4 years*

5 years*

5 years*

6 years**

6 years*

7 years**

7 years*

8 years**

8 years*

9 years*

9 years**

10 years**

10 years*

GORE® PROPATEN® Vascular Graft 32 GORE® PROPATEN® Vascular Graft

10

10

20

20

30

30

40

40

50

50

60

60

70

70

80

80

90

90

100

100

600K+ Devices implanted

2,000+ Limbs studied

30+ Clinical studies over 10 years

17+ Years of performance

GORE® PROPATEN® Vascular GraftA leading prosthetic vascular graft for lower extremity revascularization, specifically designed to reduce the risk of acute graft thrombotic failure. With more than a decade of strong performance that includes improving outcomes and reducing interventions, this longstanding bypass graft helps deliver both proven clinical and economic value for patients and hospitals.

See the proof at goremedical.com/propaten

35%N=800

A decade of performance

The GORE® PROPATEN® Vascular Graft is the leading prosthetic bypass graft solution for proven clinical performance and low cumulative cost of care.

Patients

28%Improvement in

amputation-free survival

GORE® PROPATEN® Vascular Graft long-term value†

Below-knee cumulative amputation-free survival

Decrease in average costs

Providers

38%

By substantially reducing acute graft thrombosis within hours after implantation, the CBAS Heparin Surface on the GORE® PROPATEN® Vascular Graft provides clinical benefits that standard ePTFE grafts do not.1

Fewer occlusions50% reduction in risk of graft occlusion compared to standard ePTFE in critical limb ischemia (CLI) patients.2

Improved patient outcomes

Higher primary and secondary patency, and higher limb salvage for below-knee bypass compared to standard ePTFE from 1–3 years.3

GORE® PROPATEN® Vascular Graft 54 GORE® PROPATEN® Vascular Graft

Decrease in revision procedures

Physicians

36%

71%

55%

63%62%

43%

51%

10

20

30

40

50

60

15% Improvement

24% Improvement

28% Improvement

70

Year 1 Year 1+2 Year 1+2+3

GORE® PROPATEN® Vascular Graft Standard ePTFE

Proven patency Measurable value

Amputation-free survival (avoided loss of limb or life) is the average reported mortality rate for standard ePTFE and the average reported amputation rates for standard ePTFE and GORE® PROPATEN® Vascular Graft.4

† Based on the 3-year published clinical performance and economic model.

Comparison of average cumulative treatment costs per patient years 1 to 3 post index below-knee bypass

Year 1 Year 1+2 Year 1+2+3

Graft purchase cost Graft reinterventions* Redo bypasses**

Amputation procedures Amputation rehabilitation and care

10k

20k

30k

40k

50k

60k

GORE® PROPATEN® Vascular Graft Standard ePTFE

$12,462 saved

$19,770 saved

$22,885 saved

* Procedures for restoring flow in stenosed or occuled graft ** Replacing the graft with new graft

GORE® PROPATEN® Vascular Graft3 Standard ePTFE3

Limb salvage

2

Years post-implantation

31

80

60

40

20

85% 82% 79%75%67% 63%

Secondary patency

2Years post-implantation

31

80

60

40

20

78%71%

61%58%

46% 40%

80

60

40

20

75%

65%

56%52%40%

34%

Primary patency

2

Years post-implantation

31

Improved clinical outcomes

Visit goremedical.com/cbas to learn more

GORE® PROPATEN® Vascular Graft 76 GORE® PROPATEN® Vascular Graft

Lasting thromboresistance. Proven technology.*

GORE® PROPATEN® Vascular Graft

Standard ePTFE

CBAS Heparin SurfaceThe CBAS Heparin Surface of the GORE® PROPATEN® Vascular Graft consists of a proprietary covalent end-point bond that preserves the active site, thus retaining heparin’s anticoagulant activity.

Proven heparin availability

Performance-ready heparin active site.4, 6

Proven heparin bioactivity

Unmatched, persistent ability to take up antithrombin.1, 5

Proven lasting thromboresistance

Improved surface hemocompatibility resulting from heparin availability and bioactivity.1, 4–7

In vivo canine carotid artery interposition model

Proprietary covalent end-point bonding

Sustained heparin bioactivity8

Mechanism of action

* CBAS Heparin Surface. W. L. Gore & Associates Web site. https://www.goremedical.com/cbas/references. Accessed January 9, 2019.

The CBAS Heparin Surface of a 3 mm diameter GORE® PROPATEN® Vascular Graft (top) remains free of thrombus, while the 3 mm diameter control ePTFE graft (bottom) is covered with thrombus in an acute two-hour in vivo canine carotid artery interposition model.

The anticoagulant function of heparin is dependent on the bioavailability of an active site within the molecule.

Some methods of covalent heparin bonding damage and/or obstruct the active site, and hence destroy heparin’s anticoagulant activity.

8 Years (Explant after 2,939 days)

Heparin bioactivity detected above the level required for thromboresistance in a 8-year human explant. No adherent thrombus was found.

• Femoral to posterior tibial bypass with polyester Linton patch.

• Distal anastomosis occluded.

A. Bioactive site of the heparin molecule enables antithrombin to bind thrombin.

B. When antithrombin binds to thrombin, a neutral AT-T complex is formed.

C. Neutral AT-T complex detaches from the heparin molecule.

Active site becomes available to again bind antithrombin.

Covalent end-point bonding allows the heparin to extend into the bloodstream, keeping the active site bioavailable, unlike a non-permanent bond that can be washed away in the bloodstream.

Heparin moleculewith active site Active site

Covalent end-point bonding

Material Surface Heparinmolecule with

active site

Antithrombin Conformationally altered

antithrombin

Thrombin-antithrombin

(AT-T) complex

Thrombin

Material Surface

A. B. C.