Balloon Expandable Covered Stents. Suddenly a Crowded Space

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1 Novel Balloon Expandable Covered Stents for Aorto-iliac Occlusive Disease: New Trial Data makes for an Interesting Balloon Expandable Covered Stents Comparison in Aorto-iliac Occlusive Disease: Andrew Holden Auckland Hospital Auckland, New Zealand 3 rd December 2016 Suddenly a Crowded Space Andrew Holden Auckland, New Zealand LINC 2018

2 Disclosure Speaker name: Andrew Holden... I have the following potential conflicts of interest to report: Consulting Employment in industry Stockholder of a healthcare company Owner of a healthcare company Other Clinical Investigator X I do not have any potential conflict of interest

3 Introduction Balloon expandable stents have been widely used to manage arterial occlusive disease, particularly in the aorta and it s proximal branches Features of BE stents include: High radial resistive force (resistant and calcified lesions) Accurate deployment Ability to post-dilate 3

4 Introduction Balloon expandable stents have been widely used to manage arterial occlusive disease, particularly in the aorta and it s proximal branches Features of BE stents include: High radial resistive force (resistant and calcified lesions) Accurate deployment Ability to post-dilate BE covered endoprosthesis offer additional proven and theoretical advantages: Prevent plaque protrusion through stent Prevent in-stent neointimal hyperplasia Decrease risk of complications stemming from distal embolization, perforation, rupture, or dissection 4

5 Introduction Until recently, only one BE covered endoprosthesis has been available Getinge ADVANTA Atrium V12

6 Introduction Until recently, only one BE covered endoprosthesis has been available Getinge ADVANTA Atrium V12 Suddenly the space has become more crowded!!! BARD Lifestream Bentley BeGraft Gore VBX

7 Introduction So how do we compare these devices? In what location and in what disease state should we consider each device?

8 Introduction So how do we compare these devices? In what location and in what disease state should we consider each device? Design features of each device that may indicate advantages and disadvantages Trial evidence supporting the use in clinical applications aorto-iliac occlusive disease

9 Introduction Three of 4 device trials had a similar primary composite endpoint composite of 30 day death +/- MI as well as 9 month CD-TLR (+/- patency) All 4 trials report primary patency at ~ 9 months* Allows comparison between devices * BeGraft primary patency 12 months)

10 Getinge ADVANTA Atrium V12 Available for many years with a known track record of performance eptfe fully encapsulated stainless steel stent Site reported results only Superior performance over uncovered BE stents in aorto-iliac occlusive disease clearly demonstrated J Vasc Surg

11 Getinge ADVANTA Atrium V12 Available for many years with a known track record of performance eptfe fully encapsulated stainless steel stent Site reported results only Superior performance over uncovered BE stents in aorto-iliac occlusive disease clearly demonstrated Advantage most obvious in severe (TASC C/D) disease J Vasc Surg 2016 TASC C/D LESIONS 11

12 icast Atrium Registry Ultrasound Study (icarus) A prospective multicentre non-randomized study evaluating Atrium V12 in common and/or external iliac arteries 152 patients in 25 centres All patients had claudication or rest pain (Rutherford 2-4) Lesion length < 110mm 12

13 icast Atrium Registry Ultrasound Study (icarus) 13

14 icast Atrium Registry Ultrasound Study (icarus) Primary composite endpoint 8.1% Significantly below the pre-determined performance metric of 16.6%* Primary patency 95.1% TLR 2.9% 14

15 Electropolished 316L stainless steel stent, dual layer eptfe Pre-mounted on non-compliant balloon, guidewire Radiopaque markers on balloon shaft indicate ends of covered stent / F 7F 8F 80cm, 135cm catheters CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

16 Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease Design Prospective, Multi-Center, Non-Randomized, Single-Arm Study Objective ITT Population Assess the safety and effectiveness of the LIFESTREAM Balloon Expandable Vascular Covered Stent for the treatment of stenoses and occlusions in the common and/or external iliac arteries 155 patients at 17 investigational sites (US, Europe, New Zealand) CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

17 Baseline Characteristics ITT Group Auckland City Hospital Number of Patients Age, years Male/Female, % 69/31 81/19 Weight, kg BMI, kg/m TASC Classification [1] A 96 (61.9%) 14 (66.7%) B 42 (27.1%) 5 (23.8%) C 15 (9.7%) 2 (9.5%) D 2 (1.3%) 0 (0.0%) BPV/SGF1/1016/

18 Lesion Characteristics ITT Group Auckland City Hospital Number of Lesions Mean Lesion Length, mm Vessel, % (n) Common Iliac 73.4 (141) 65.5 (19) External Iliac 26.6 (51) 34.5 (10) Moderate/Severe Calcification, % (n) 64.5 (127) 48.3 (14) Occlusion, % (n) 10.7 (21) 6.9 (2) Pre-% Diameter Stenosis CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

19 9 Month Results: Primary composite endpoint 11.6% Significantly below the pre-determined performance metric of 19.5%* Primary patency 89.1% TLR 4.3% * Derived from iliac stent published literature BPV/SGF1/1016/

20 Actual Case 66 year old male, TASC B Lesion Right leg claudication, Rutherford 3 CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

21 CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

22 CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

23 CAUTION: Investigational Device - Limited by Federal (USA) Law to Investigational Use BPV/SGF1/1016/

24 BeGraft Peripheral Stent Graft System from Bentley Stent Material: CoCr versus Stainless steel eptfe cover at 200um thickness not attached to stent struts eptfe cover folded in at both ends

25 BeGraft Peripheral Stent Graft System Performance testing 25

26 BeGraft Peripheral Stent Graft System Performance testing radial resistive force 26

27 BeGraft Peripheral Stent Graft System Performance testing - trackability 27

28 BeGraft Peripheral Stent Graft System BeGraft Peripheral Study Prospective, non randomised multicentre study N = 70 Patients TASC Classification A 77 B 14 C 6 D 3 Mean Lesion Length 34.3mm Mean degree of Stenosis 83.2 Deloose et al. J Cardiovasc Surg 2017 May 28

29 BeGraft Peripheral Stent Graft System BeGraft Peripheral Study Prospective, non randomised multicentre study N = 70 Patients TASC Classification A 77 BPrimary Patency at months 94% CFreedom from TLR 697% D 3 Mean Lesion Length 34.3mm Mean degree of Stenosis 83.2 Deloose et al. J Cardiovasc Surg 2017 May 29

30 BeGraft Plus Peripheral Stent Graft System Newest generation of BeGraft Sandwich design consisting of 2 layers of eptfe and internal and external stents Achieves superior radial force while achieving enhanced flexibility

31 Technology & clinical benefits of GORE VIABAHN VBX Balloon Expandable Endoprosthesis FEATURES Discrete, fluoropolymer-connected stainless steel rings BENEFITS Flexibility, conformability and trackability High radial strength Minimal foreshortening Ultrathin fluoropolymer balloon cover Improved endoprosthesis retention on delivery catheter CBAS Heparin Surface on the device similar to GORE VIABAHN Endoprosthesis Thromboresistant surface 31

32 Study configurations available Stent Labeled Diameter (mm) Max Post-Dilated Stent Diameter (mm) Crimped Stent Length (mm) Introducer Sheath Size (Fr) Rated Burst Pressure (atm) , 19, 39, , 19, 39, , 19, 39, , , , All configurations available in OTW 80 and 135 cm catheter lengths 32

33 VBX FLEX Clinical Study Overview 33

34 Clinical Endpoints at Nine Months Primary composite endpoint 2.3% Primary patency 96.9% TLR 2.6% 34

35 Complex Case Example 68 year old male Bilateral thigh and calf claudication Severely atheromatous aortoiliac arteries RCIA CTO, LCIA stenosis Performed as a Live case at VIVA

36 Complex Case Example 36

37 Stent Deployment (Ends to Middle) stent graft stent graft 37

38 38

39 Stent Post-dilatation Labeled device diameter (mm) Max Endoprosthesis expanded diameter (mm)

40 Complex Case Example stent graft stent graft 40 CE Mark Pending. This device is not commercially available and will only be available on the market when the CE mark can be applied by W.L. Gore & Associates.

41 Device Comparisons ability to post-dilate Stent Labeled / Nominal Diameter (mm) VIABAHN VBX Max. Post-Dilated Stent Diameter (mm) L 16 Unique configurations 76 *Bard LifeStream Max. Post-Dilated Stent Diameter (mm) Stent Labeled / Nominal Diameter (mm) Unique configurations 38 *Maquet ADVANTA V12 Stent Labeled / Nominal Diameter (mm) Max. Post-Dilated Stent Diameter (mm) Unique configurations 34 *Bentley BeGraft Stent Labeled / Nominal Diameter (mm) Max. Post-Dilated Stent Diameter (mm) Unique 48 configurations *Information obtained from product Instructions for Use 41

42 Device Comparisons icarus Bolster BeGraft VBX Lesion length (mm) o Composite endpoint 8.1% 11.6% NR 2.3% Patency 95.1% 89.7% 94.0% 96.7% Freedom from TLR 97.2% 96.7% 97% 97.4% 42

43 Device Comparisons icarus Bolster BeGraft VBX Lesion length (mm) o Composite endpoint 8.1% 11.6% NR 2.3% Patency 95.1% 89.7% 94.0% 96.7% Freedom from TLR 97.2% 96.7% 97% 97.4% 43

44 Conclusions Balloon expandable covered stents is now a much more crowded space! Getinge Atrium V12 has the advantage of a long history of reliability and predictability with more extensive clinical data 44

45 Conclusions Balloon expandable covered stents is now a much more crowded space! Getinge Atrium V12 has the advantage of a long history of reliability and predictability with more extensive clinical data The newer BE endografts have some unique design features It is likely that all devices will perform well in relatively simple disease eg TASC A, B and C iliac occlusive disease Other issues such as clinical support and price may be relevant in deciding devices for these cases 45

46 Conclusions In complex occlusive disease (eg TASC D aorto-iliac lesions), the additional confirmability of VBX may offer improve patency 46

47 Conclusions In complex occlusive disease (eg TASC D aorto-iliac lesions), the additional confirmability of VBX may offer improve patency The additional flexibility of VBX and BeGraft may offer advantages in parallel graft applications 47

48 Novel Balloon Expandable Covered Stents for Aorto-iliac Occlusive Disease: New Trial Data makes for an Interesting Balloon Expandable Covered Stents Comparison in Aorto-iliac Occlusive Disease: Andrew Holden Auckland Hospital Auckland, New Zealand 3 rd December 2016 Suddenly a Crowded Space Andrew Holden Auckland, New Zealand LINC 2018

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