Powerful patency. A decade of performance.

Transcription

1 Above-knee Data 1 Year a : 84% N=528 2 Years a : 78% N=320 3 Years a : 76% N=222 Powerful patency. A decade of performance. Below-knee Data 1 Year a : 76% N=745 2 Years a : 67% N=631 3 Years a : 60% N=477 4 Years a : 45% N=631 5 Years b : 52% N=212 9 Years b : 41% N=212 Overall weighted average primary patency More Data. More Patients. More Confidence. * LITERATURE SUMMARY

2 Weighted Average = (N 1 x Primary Patency 1 ) + (N 2 x PP 2 ) (N n x PP n ) N 1 + N N n * Data based on an analysis of current literature: several MEDLINE Database searches were performed to identify publications pertaining to eptfe synthetic vascular graft and vein infragenicular bypasses. Search criteria included (1) articles published from January 2000 to January 2012, (2) key words used were below knee, polytetrafluoroethylene, prosthetic, bypass, patency, (3) articles in English language, (4) N equal or greater than 30 bypasses, (5) clinical publications, (6) reviews, case reports or meta-analysis articles were excluded, (7) articles containing the key word AV access (including synonyms) were excluded. Articles that did not meet the above criteria were deemed ineligible for this analysis. Data of analysis on file. In studies where 1-year and 3-year patency data were reported, but 2-year patency data were not reported, the 2-year patency rate used in this analysis was interpolated as the average of the 1-year and 3-year patency rates. Below-knee (BK) inclusion criteria for GORE PROPATEN Vascular Graft literature used in this analysis were (1) articles in English language, (2) clinical journal articles or book chapters, (3) non-overlapping patient populations, (4) BK bypass primary patency reported for at least 12 months of follow-up, and (5) N = 50 or more BK bypasses. Additional exclusion criteria were (1) reviews, case reports or meta-analysis articles, and (2) articles containing the key word AV access (including synonyms). Data of analysis on file.

3 Overall Weighted Average Primary Patency in Below-knee Bypasses 1 Year 2 Years 60%* 76% eptfe GORE PROPATEN Vascular Graft Vascular Graft (N = 2,549) (N = 745) %* eptfe Vascular Graft (N = 2,249) 67% GORE PROPATEN Vascular Graft (N = 631) 79%* Vein (N = 11,956) 77%* Vein (N = 10,458) Below-knee Bypasses Years 40%* eptfe Vascular Graft (N = 1,941) 60% GORE PROPATEN Vascular Graft (N = 477) 75%* Vein (N = 9,867) Years 29%* 45% eptfe GORE PROPATEN Vascular Graft Vascular Graft (N = 599) (N = 631) 72%* Vein (N = 9,260) [ 2 ]

4 Summary of Primary Patency from GORE PROPATEN Vascular Graft Literature in Below-knee Bypasses Overall Weighted Average Primary Patency TOTAL N = % 67 % 1 year 2 years BK Fem-Pop N = % 71% BK Infrapopliteal N = % 62% 60 % 3 years 64% 53% 45 % 4 years 47% 42% N = Number of bypasses Monaca, et al BK Fem-Pop N = % 41.2 % 5 years 9 years Lösel-Sadée, et al BK Fem-Pop N = % 71.4 % 71.4 % 71.4 % UD * 1 year 2 years 3 years 4 years 5 years BK Fem-Crural N = % 56.8 % 49.7 % 49.7 % 49.7 % * UD: undeterminable because of small patient numbers Dorigo, et al BK Fem-Pop N = % 4 years BK Infrapopliteal N = % Pulli, et al BK Fem-Pop N = % 67 % 61 % 1 year 2 years 3 years [ 3 ] BK Infrapopliteal N = % 57 % 52 %

5 Peeters, et al Below-knee Bypasses BK Fem-Pop N = % 79 % 75 % 1 year 2 years 3 years BK Infrapopliteal N = % 60 % 60 % Daenens, et al BK Fem-Pop N = % 83 % 1 year 2 years BK Infrapopliteal N = % 69 % Neville, et al BK Fem-Distal N = % 1 year Hugl, et al BK Fem-Pop N = % 1 year BK Infrapopliteal N = % [ 4 ]

6 Subpopliteal revascularization. Criteria analysis for the use of eptfe [GORE PROPATEN Vascular Graft] as first choice conduit: Multicenter Italian Registry Group V. Monaca, et al. 1 Vittorio Emanuele Policlinic University Hospital Presidio Ospedaliero Ferrarotto, Catania, Italy BK Fem-Pop N = % 41.2 % 5 years 9 years Patient Characteristics Rutherford Classification 3 41% 4 43% 5 16% Proximal Anastomosis Number of Bypasses Common femoral artery 212 Distal Anastomosis Number of Bypasses BK popliteal 154 TP trunk 58 Retrospective analysis of multi-center registry data Patients were considered at a low risk for thrombosis: exclusion criteria included re-do operations, poor plantar and perimalleolar circulation, severe tissue loss, and single-vessel runoff Secondary patency at 5 and 9 years was 58.3%, and limb salvage at 5 and 9 years was 93.1% Conclusion in low thrombotic risk patients mid-and long-term patency of vein and Propaten graft [GORE PROPATEN Vascular Graft] is comparable. In case of PTFE use, we reported shorter surgery time, reduced hospital stay and wound complications. These observations led us to primarily choose the prosthetic graft in that subset of cases, saving the VSG [great saphenous vein] for distal revascularization in case of occlusive disease progression. V. Monaca [ 5 ]

7 Heparin-bonded expanded polytetrafluoroethylene graft for infragenicular bypass: 5-year results H. Lösel-Sadée and C. Alefelder 2 Department of Vascular Surgery Sana Kliniken Dusseldorf, Dusseldorf, Germany BK Fem-Pop BK Fem-Crural N = 30 N = % 1 year 2 years 64.4 % 71.4 % 56.8 % 71.4 % 49.7 % 71.4 % 49.7 % UD * 3 years 4 years 5 years 49.7 % * UD: undeterminable because of small patient numbers Below-knee Bypasses Patient Characteristics Number of Bypasses BK fem-pop 30 Fem-crural 45 i) Anterior tibial 14 ii) Tibioperoneal trunk 12 iii) Posterior tibial 9 iv) Peroneal 9 v) Dorsalis pedis 1 Retrospective single-center study Vein cuffs were created at the distal anastomosis in 5 patients; no patches were used The 3-year and 4-year secondary patency rates for below-knee fem-pop and fem-crural bypasses were 82.5% and 71.5%, respectively The 5-year limb salvage rate was 84% [ 6 ]

8 Results from an Italian multicentric registry comparing heparin-bonded eptfe graft and autologous saphenous vein in below-knee popliteal bypasses W. Dorigo, et al. 3 Department of Vascular Surgery, University of Florence, Florence, Italy BK Fem-Pop N = % 4 years BK Infrapopliteal N = % Patient Characteristics Diabetes 45.5% ESRD 15% Hypertension 87% Smoking 72% Hyperlipidemia 59% Coronary artery disease 45% Distal Anastomosis Number of Bypasses BK popliteal 414 T-P trunk 69 Anterior tibial 27 Posterior tibial 35 Peroneal 11 Retrospective analysis of a multi-center registry of GORE PROPATEN Vascular Graft and autologous saphenous vein There was no statistically significant difference in secondary patency or limb salvage between GORE PROPATEN Vascular Graft and autologous saphenous vein Conclusion we had a 13% increase in secondary patency rates in eptfe group, whereas the corresponding figure was only 6% in patients with occluded vein, thus confirming both the possibility of effectively treating occluded heparin-bonded grafts and the difficulty of dealing with occluded vein bypasses. In patients with critical limb ischemia, the rates both of amputations at 4 years and of amputation-free survival were not different between autologous vein and heparin-bonded eptfe and this is an encouraging result, considering that limb salvage probably represents the main outcome in all these critical patients. W. Dorigo [ 7 ]

9 Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded eptfe graft: Italian Registry Group R. Pulli, et al. 4 Department of Vascular Surgery, University of Florence, Italy BK Fem-Pop BK Infrapopliteal N = 238 N = % 1 year 2 years 66 % 67 % 61 % 3 years 57 % 52 % Below-knee Bypasses Patient Characteristics (Total N = 425) * Rutherford Classification 4 54% 5 34% 6 12% Runoff Score % % Adjunctive Procedures Distal Anastomosis Vein cuff 10.5% Patching 5% Tibial angioplasty 1% Other procedures 3% Multi-center, retrospective, non-randomized study All patients had Critical Limb Ischemia (CLI) Combined fem-pop and infrapopliteal limb salvage rate at 3 years was 81% in these CLI patients Conclusion the good results at 3 years in primary interventions in patients with more than one distal vessel and with rest pain could suggest a significant role of the heparin-bonded graft in these subgroups of patients. R. Pulli Primary and secondary patency rates make this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality. R. Pulli * Includes 101 patients with AK bypasses [ 8 ]

10 Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? P. Peeters, et al. 5 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium BK Fem-Pop N = % 79 % 75 % 1 year 2 years 3 years BK Infrapopliteal N = % 60 % 60 % Patient Characteristics Number of Bypasses BK fem-pop 41 Fem-crural 37 i) Fem-anterior tibial artery 10 ii) Fem-tibiofibular trunk 11 iii) Fem-posterior tibial artery 10 iv) Fem-peroneal artery 6 Prospective, multi-center study No adjunctive techniques (patches or cuffs) were used in the study The 3-year secondary patency rate for below-knee fem-pop and fem-crural bypasses were 80% and 62%, respectively The 3-year limb salvage rate for all CLI patients was 86%* Conclusion PROPATEN Vascular Graft [GORE PROPATEN Vascular Graft] may succeed in bridging the gap between venous and regular PTFE bypass...especially for infrapopliteal bypasses. P. Peeters * Limb salvage rates are for both above-knee and below-knee bypasses. [ 9 ]

11 Heparin-bonded eptfe grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results K. Daenens, et al. 6 University Hospital Gasthuisberg, Belgium BK Fem-Pop BK Infrapopliteal N = 57 N = 97 Patient Characteristics 92 % 83 % 1 year 2 years 79 % 69 % Below-knee Bypasses Number of Bypasses BK fem-pop 57 Fem-crural 97 i) Fem-tibiofibular trunk 10 ii) Fem-anterior tibial artery 37 iii) Fem-fibular (peroneal) artery 21 iv) Fem-posterior tibial artery 29 Retrospective, non-randomized study Study compared results from GORE PROPATEN Vascular Graft to autologous vein bypasses Adjunctive techniques: Below-knee fem-pop: 2 Miller cuff, 2 Taylor patch, 2 Linton patch Below-knee fem-crural: 11 Miller cuff, 3 Taylor patch, 7 Linton patch, 15 AV fistula The 2-year limb salvage rates for below-knee fem-pop and fem-crural bypasses were 98% and 87%, respectively 2-year autologous vein patency rates for below-knee fem-pop and infrapopliteal were 72% and 64%, respectively Conclusion In this large retrospective study, heparin-bonded eptfe grafts had 1- and 2-year primary patency results that were not significantly different from those for ASV grafts. Results in BK FP and FC applications were especially promising. K. Daenens Overall, our results...provide solid additional evidence that heparin-bonded eptfe grafts represent an important new option in the treatment of peripheral arterial disease. K. Daenens [ 10 ]

12 A comparison of tibial artery bypass performed with heparin-bonded expanded polytetrafluoroethylene and great saphenous vein to treat critical limb ischemia R. Neville, et al. 7 Division of Vascular Surgery, George Washington University, Washington, DC, USA BK Fem-Distal N = % 1 year Patient Characteristics Rutherford Classification 3 8% 4 27% 5 48% 6 16% Prior bypass 44% Diabetes 47% ESRD 13% Hypertension 73% Distal Anastomosis Number of Bypasses Anterior tibial 15 Posterior tibial 22 Peroneal 21 Dorsalis pedis 4 Retrospective single-center study comparing GORE PROPATEN Vascular Graft to great saphenous vein Distal vein patch was used at all distal anastomoses There was no statistically significant difference in primary patency or limb salvage between GORE PROPATEN Vascular Graft and single-segment great saphenous vein Conclusion This experience with heparin-bonded eptfe grafts for solely tibial artery bypass yielded patency and limb salvage rates that are comparable to intact great saphenous vein. We believe that a quality saphenous vein remains the ideal conduit for tibial bypass, although HePTFE should be considered when intact ipsilateral or contralateral vein is not available. In our practice, HePTFE has emerged as the choice over arm vein, especially in the ESRD patient who needs upper extremity vein for dialysis access. We would also choose HePTFE over composite short saphenous vein given the increased dissection required and length of conduit. R. Neville [ 11 ]

13 PEPE II a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below-knee bypass surgery: determinants of patency B. Hugl, et al. 8 Department of Vascular Surgery, Medical University, Innsbruck, Austria BK Fem-Pop BK Infrapopliteal N = 37 N = % 1 year 79 % Below-knee Bypasses Patient Characteristics (Total N = 139) Vessel Run-off Scores * 1 Vessel 29% 2 Vessels 36% 3 Vessels 34% Fontaine Classification Stage * Stage I < 1% Stage II 45% Stage III 19% Stage IV 36% Prospective, multi-center study Patients without suitable autologous vein The 1-year secondary patency rates for below-knee fem-pop and fem-distal bypasses were 79% and 85%, respectively Overall 1-year patency and limb salvage rates were 80% and 96%, respectively * Conclusion present data show that using the endpoint heparin bonded eptfe graft for lower limb revascularization produces excellent results for AK bypasses and encouraging results for BK bypasses, when compared with data obtained from studies which used other prosthetic material. These encouraging results for BK bypasses were even seen in the subgroup of patients that generally have worse revascularization results due to the presence of risk factors. B. Hugl our data suggests that the use of this graft is an excellent option when no autologous vein is available. B. Hugl * Includes 87 patients with AK bypasses [ 12 ]

14 Weighted Average = (N 1 x Primary Patency 1 ) + (N 2 x PP 2 ) (N n x PP n ) N 1 + N N n * Above-knee (AK) inclusion criteria for GORE PROPATEN Vascular Graft literature used in this analysis were (1) articles in English language, (2) clinical journal articles or book chapters, (3) non-overlapping patient populations, and (4) AK bypass primary patency reported for at least 12 months of follow-up. Additional exclusion criteria were (1) reviews, case reports or meta-analysis articles, and (2) articles containing the key word AV access (including synonyms). Data of analysis on file.

15 Overall Weighted Average Primary Patency in Above-knee Bypasses * 1 Year 84% GORE PROPATEN Vascular Graft (N = 528) Years 78% GORE PROPATEN Vascular Graft (N = 320) Years 76% GORE PROPATEN Vascular Graft (N = 222) Above-knee Bypasses [ 14 ]

16 Summary of Primary Patency from GORE PROPATEN Vascular Graft Literature in Above-knee Bypasses Overall Weighted Average Primary Patency AK Fem-Pop N = % 78 % 1 year 2 years 76 % 3 years N = Number of bypasses Samson, et al AK Fem-Pop N = % 87.8 % 87.8 % 1 year 2 years 3 years Lindholt, et al AK Fem-Pop N = % 1 year Kirkwood, et al AK Fem-Pop N = 9 86 % 1 year Pulli, et al AK Fem-Pop N = % 72 % 72 % 1 year 2 years 3 years [ 15 ]

17 Peeters, et al AK Fem-Pop N = % 77.6 % 75.4 % 1 year 2 years 3 years Daenens, et al AK Fem-Pop N = % 83 % 1 year 2 years Walluschek, et al AK Fem-Pop N = % 68 % 1 year 2 years Above-knee Bypasses [ 16 ]

18 Improved three year patency rates for heparin-bonded eptfe femoropopliteal bypass grafts versus eptfe grafts without heparin R. Samson and L. Morales 9 Florida State University Medical School, Sarasota, Florida, USA AK Fem-Pop N = % 87.8 % 87.8 % 1 year 2 years 3 years Patient Characteristics (GORE PROPATEN Vascular Graft Group, N = 70) * Diabetes 48.6% Hypertension 81.4% Smoking 34.3% Hyperlipidemia 72.9% Coronary artery disease 47.1% Indication for Bypass Claudication 34.3% Rest pain 27.1% Ulceration 35.7% Gangrene 21.4% Retrospective, single-center study of GORE PROPATEN Vascular Graft (2007 present) and standard eptfe grafts ( ) There was a statistically significant difference in primary patency between GORE PROPATEN Vascular Graft and standard eptfe from 1 through 3 years Conclusion Based on our data we will preferentially use heparin-bonded expanded polytetrafluoroethylene for above-knee femoropopliteal bypasses except in young patients who have available suitable autogenous saphenous vein. The three-year patency for above-knee heparin-bonded expanded polytetrafluoroethylene described in our series is similar to reported patency rates for autogenous saphenous vein (87.8%). R. Samson * Includes 24 patients with BK bypasses. [ 17 ]

19 The Scandinavian Propaten [GORE PROPATEN Vascular Graft] Trial 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses a randomised clinical controlled multi-centre trial J. Lindholt, et al. 10 Vascular Research Unit, Department of Vascular Surgery, Viborg Hospital, Denmark AK Fem-Pop N = % 1 year Patient Characteristics (GORE PROPATEN Vascular Graft Group, N = 272) * Smokers 53.3% Diabetes mellitus 15.0% Critical limb ischemia 36.0% Total N = 546 patients Multi-center (11 centers), prospective, randomized study comparing GORE PROPATEN Vascular Graft versus standard eptfe Fem-pop (majority above-knee) and fem-fem bypasses Statistically significant improvement in primary and secondary patency with GORE PROPATEN Vascular Graft versus standard eptfe for all bypasses In fem-pop patients with CLI, GORE PROPATEN Vascular Graft primary patency was 80% while standard eptfe patency was 58% (p < 0.05) Conclusion GORE PROPATEN Vascular Graft reduced the risk of graft occlusion by 40% overall, and by 50% in patients with CLI. We have seen that the GORE PROPATEN Vascular Graft keeps its promise as shown in previously conducted prospective and retrospective studies. Jes S. Lindholt, MD, PhD * Includes 160 patients with fem-fem bypasses. Above-knee Bypasses [ 18 ]

20 Lower limb revascularization for PAD using GORE PROPATEN Vascular Graft M. Kirkwood, et al. 11 Division of Vascular Surgery and Endovascular Therapy University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA AK Fem-Pop N = 9 86 % 1 year Patient Characteristics (Total N = 68) Characteristic * Critical limb ischemia 67% 1 2 vessel runoff score 60% Diabetes 41% Indications for Surgery * Diabling claudication 33% Rest pain 34% Tissue loss 33% Retrospective, single-center, single-arm study Patients did not have appropriate autologous vein 18-month follow-up Primary patency rates at 18 months for fem-fem (n = 22) and ax-fem (n = 7) bypasses were 95% and 100%, respectively Conclusion when appropriate autologous vein is not available or the integrity of existing vein is questionable for infrainguinal bypass, the PROPATEN graft [GORE PROPATEN Vascular Graft] is an excellent alternative with impressive patency and low morbidity. M. Kirkwood These results are especially encouraging, when the severity of patient disease is considered M. Kirkwood These results, especially in the BK and the tibial bypasses, have been better than our own historical experience with standard PTFE, and therefore we have altered practice to include using PROPATEN [GORE PROPATEN Vascular Graft] when a prosthetic conduit is necessary. M. Kirkwood * Includes 29 patients with BK bypasses, 22 with fem-fem bypasses, 7 with ax-fem bpyasses, and 1 with an ilio-fem bypass. [ 19 ]

21 Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded eptfe graft R. Pulli, et al. 4 Department of Vascular Surgery, University of Florence, Italy AK Fem-Pop N = % 72 % 72 % 1 year 2 years 3 years Patient Characteristics (Total N = 425) * Rutherford Classification 4 54% 5 34% 6 12% Runoff Score % % Multi-center, retrospective, non-randomized study All patients had critical limb ischemia The above-knee fem-pop limb salvage rate at 3 years was 87% Conclusion the good results at 3 years in primary interventions in patients with more than one distal vessel and with rest pain could suggest a significant role of the heparin-bonded graft in these subgroups of patients. R. Pulli Primary and secondary patency rates make this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality. R. Pulli * Includes 324 patients with BK bypasses Above-knee Bypasses [ 20 ]

22 Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? P. Peeters, et al. 5 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium AK Fem-Pop N = % 77.6 % 75.4 % 1 year 2 years 3 years Patient Characteristics (Total N = 138) * Rutherford 3 56% Rutherford 4 19% Rutherford 5 25% Diabetes 27% Hypertension 64% Coronary artery disease 30% Nicotine use 48% Prospective, multi-center study No adjunctive techniques (patches or cuffs) were used in the study 73% of patients had been previously treated for Peripheral Vascular Disease (PVD) The 3-year limb salvage rate for all Critical Limb Ischemia (CLI) patients was 86% ** Conclusion it is our opinion that the Propaten Vascular Graft [GORE PROPATEN Vascular Graft] may succeed in bridging the gap between venous conduits and regular eptfe grafts. P. Peeters * Includes patients that underwent 97 BK bypasses. ** Limb salvage rates are for both above-knee and below-knee bypasses. [ 21 ]

23 Heparin-bonded eptfe grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results K. Daenens, et al. 6 University Hospital Gasthuisberg, Belgium AK Fem-Pop N = % 83 % 1 year 2 years Patient Characteristics (GORE PROPATEN Vascular Graft Group) Rutherford 3 26% Rutherford 4 25% Rutherford 5 35% Rutherford 6 7% Smokers 62% Re-do bypass 36% Retrospective, non-randomized study Study compared results from GORE PROPATEN Vascular Graft to autologous vein bypasses The 1 and 2 year primary patency rates for above-knee fem-pop bypasses using autologous vein were 91% and 80%, respectively Conclusion Overall, our results...provide solid additional evidence that heparin-bonded eptfe grafts represent an important new option in the treatment of peripheral arterial disease. K. Daenens Above-knee Bypasses [ 22 ]

24 Infrainguinal eptfe vascular graft with bioactive surface heparin bonding first clinical results K.P. Walluscheck, et al. 12 University Hospital Schleswig-Holstein / Campus Kiel, Germany AK Fem-Pop N = % 68 % 1 year 2 years Patient Characteristics Fontaine Class Number of Bypasses Stage II b 3 Stage III 3 Stage IV 6 Retrospective study Patients with lack of or inadequate saphenous vein Linton patch was used in 2 cases for distal anastomoses to the above-knee popliteal artery After 2 years, the limb salvage rate was 98% * Conclusion...the bioactive heparinized eptfe graft evaluated in this study provides patency rates comparable with autologous vein grafts.,...at our department the Propaten graft [GORE PROPATEN Vascular Graft] is the prosthesis of choice when autologous vein is not available. K.P. Walluscheck * Limb salvage rates are for both above-knee and below-knee bypasses. [ 23 ]

25 Above-knee Bypasses

26 REFERENCES 1. Monaca V, Battaglia G, Turiano SA, Tringale R, Catalfamo S. Sub popliteal revascularization. Criteria analysis for use of E-P.T.F.E. (Propaten ) as first choice conduit. Italian Journal of Vascular & Endovascular Surgery 2013;20(3): Lösel-Sadée H, Alefelder C. Heparin-bonded expanded polytetrafluoroethylene graft for infragenicular bypass: five-year results. Journal of Cardiovascular Surgery 2009;50(3): Dorigo W, Raffaele P, Piffaretti G. Results from an Italian multicentric registry comparing heparin-bonded eptfe graft and autologous saphenous vein in below-knee femoro-popliteal bypasses. Journal of Cardiovascular Surgery 2012;53(2): Pulli R, Dorigo W, Castelli P, et al; Propaten Italian Registry Group. Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded eptfe graft. Journal of Vascular Surgery 2010;51(5): Peeters P, Verbist J, Deloose K, Bosiers M. Will heparin-bonded PTFE replace autologous venous conduits in infrapopliteal bypass? Italian Journal of Vascular & Endovascular Surgery 2008;15(3): Daenens K, Schepers S, Fourneau I, Houthoofd S, Nevelsteen A. Heparin-bonded eptfe grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results. Journal of Vascular Surgery 2009;49(5): Neville RF, Capone A, Amdur R, Lidsky M, Babrowicz J, Sidawy AN. A comparison of tibial artery bypass performed with heparinbonded expanded polytetrafluoroethylene and great saphenous vein to treat critical limb ischemia. Journal of Vascular Surgery 2012;56(4): Hugl B, Nevelsteen A, Daenens K, et al; PEPE II Study Group. PEPE II - a multicenter study with an end-point heparin-bonded expanded polytetrafluoroethylene vascular graft for above and below knee bypass surgery: determinants of patency. Journal of Cardiovascular Surgery 2009;50(2): Samson RH, Morales L. Improved three year patency rates for heparin-bonded eptfe femoropopliteal bypass grafts vs. eptfe grafts without heparin. In: Greenhalgh RM, ed. Vascular & Endovascular Challenges Update. London, UK: BIBA Publishing; 2013: 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 randomised clinical controlled multi-centre trial. European Journal of Vascular & Endovascular Surgery 2011;41(5): Kirkwood ML, Wang GJ, Jackson BM, Golden MA, Fairman RM, Woo EY. Lower limb revascularization for PAD using a heparincoated PTFE conduit. Vascular & Endovascular Surgery 2011;45(4): Walluscheck KP, Bierkandt S, Brandt M, Cremer J. Infrainguinal eptfe vascular graft with bioactive surface heparin bondingfirst clinical results. Journal of Cardiovascular Surgery 2005;46(4): [ 25 ]

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28 COVER PAGE REFERENCES: * As compared to clinical studies listed on clinicaltrials.gov for peripheral arterial bypass. a. Overall weighted average primary patency is based on data from 11 peer-reviewed publications meeting pre-determined inclusion criteria. Visit goremedical.com/propatenperformance to see inclusion criteria, explore the data, see publications, and request reprints. b. Monaca V, Battaglia G, Turiano SA, Tringale R, Catalfamo S. Sub popliteal revascularization. Criteria analysis for use of E-P.T.F.E. (Propaten ) as first choice conduit. Italian Journal of Vascular & Endovascular Surgery. In press. W. L. Gore & Associates, Inc. Flagstaff, AZ (Asia Pacific) (United States) (Europe) (United States) goremedical.com Products listed may not be available in all markets. GORE, PERFORMANCE THROUGH DATA, PROPATEN, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc. AT0145-EN1 APRIL 2014