Andrew Holden, MBChB, FRANZCR

GORE® VIABAHN® BX Endoprosthesis

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.

A New More Conformable Covered Stent From GORE®:

Advantages, Limitations and Clinical Results

AnAlternativeTreatmentOptionforCalcifiedLesionsintheIliac

Arteries

AndrewHolden

AucklandHospital

Auckland,NewZealand

LINC2017– January24th 2017

Disclosures

• Andrew Holden is a Clinical Investigator involved in the US

IDE Study evaluating the GORE® VIABAHN® Balloon

Expandable Endoprosthesis

• No other relevant disclosures

Caution: Investigational Device. Limited by United States to Investigational Use Only

Disclosure

Speaker name:

Andrew Holden

I have the following potential conflicts of interest to report:

Consulting - ClinicalInvestigatorinvolvedintheUSIDEStudyevaluatingtheGORE® VIABAHN® BalloonExpandableEndoprosthesis

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I

XX

Aorto-Iliac Occlusive Disease (AIOD) – Clinical

Challenges and Unmet Needs

• Although current TASC II guidelines

recommend surgery for type C & D

lesions, an “endovascular first” approach

is favoured for almost all AIOD

• Stent-grafts offer proven and theoretical

advantages for complex lesions:

– Prevent plaque protrusion through

stent

– Prevent in-stent neointimal

hyperplasia

– Decrease risk of complications

stemming from distal embolization,

perforation, rupture, or dissection

3

Aorto-Iliac Occlusive Disease (AIOD) – Clinical

Challenges and Unmet Needs

• Although current TASC II guidelines

recommend surgery for type C & D

lesions, an “endovascular first” approach

is favoured for almost all AIOD

• Stent-grafts offer proven and theoretical

advantages for complex lesions:

– Prevent plaque protrusion through

stent

– Prevent in-stent neointimal

hyperplasia

– Decrease risk of complications

stemming from distal embolization,

perforation, rupture, or dissection

4

• Studies have shown a clinical benefit with balloon-expandable stent-grafts in complex TASC II C & D lesions (e.g. COBEST Trial)

5

Iliac Occlusive Disease – Clinical Challenges

and Unmet Needs

J Vasc Surg 2016

• Until recently, there has been only 1

balloon expandable stent-graft

available – the Maquet Atrium V12

• While this device has performed

well, there are opportunities for

improvement

6

Iliac Occlusive Disease – Clinical Challenges

and Unmet Needs

• Flexibility (on catheter and implanted)– Trackability through tortuous

vessels

– Conformability once implanted

– Low incidence of stent fractures, failures

• Improved stent retention on delivery system – Accurate placement

– Minimal foreshortening

– Prevent distal embolization

GORE® VIABAHN® BX Endoprosthesis

New Gore VIABAHN® Balloon Expandable Stent-Graft

1-Year Results In Treating Iliac Artery Occlusive Disease:

The First-in-Human Trial

7

Technology & clinical benefits of

GORE® VIABAHN® Balloon Expandable Endoprosthesis

FEATURES

• Discrete, ePTFE-connected stainless steel rings----------

• 0.035” guidewire compatible, ultrathin ePTFE balloon cover -----------------------------------------------------------------

• CBAS® Heparin Surface on the device similar to

VIABAHN® endoprosthesis and TIGRIS® vascular stent

BENEFITS

• Flexibility, conformability and trackability

• High radial strength

• Minimal foreshortening

• Improved endoprosthesis retention on delivery catheter

8

• Thromboresistant surface

GORE® VIABAHN® Balloon Expandable

Endoprosthesis configurations

Labeled device diameter (mm)

Max Endoprosthesis

expanded diameter (mm)

Crimped stent length (mm)

Introducer sheath size (Fr)

Rated burst pressure (atm)

5 8 15, 19, 39, 59 7 15

6 8 15, 19, 39, 59 7 15

7 11 15, 19, 39, 59 7 15

8 11 39, 59 7 13

9 13 39, 59 8 13

10 13 39, 59 8 13

All configurations available in 0.035” OTW 80 and 135 cm catheter lengths

9

• Ends-to-middle balloon inflation (dogbone)

• Minimal foreshortening

• Accurate placement

• High radial resistive force to manage calcification

• Broad compliance curve for diameter adjustability

• Minimal recoil

• Short balloon deflation time

Deployment Performance

First-in-Human Clinical Study Design

• Auckland City Hospital, Auckland NZ. PI: Dr. Andrew Holden

• Prospective, single-center, single-arm clinical study (N=30 patients)

• Key Eligibility criteria

– De novo or restenotic lesions in common and external iliac

arteries

– Rutherford Category 2-4

– Up to 2 discrete lesions per patient, with up to 3 study devices

– Unilateral or bilateral treatment, including kissing stents

• Follow-up out to 3 years

11

Holden et al, J Endovasc Ther 2017:24:in press

Patient and lesion characteristics (N=30 patients)

Age, y 64

Men 18 (60)

Rutherford category

2 5 (17)

3 24 (80)

4 1 (3)

Smoking history 30 (100)

Diabetes mellitus 6 (20)

Hypertension 23 (77)

Hyperlipidemia 22 (73)

Coronary artery disease 10 (33)

TASC II Classification

A 7 (23)

B 9 (30)

C 14 (47)

D 0

12

Patient and lesion characteristics (N=30 patients)

Age, y 64

Men 18 (60)

Rutherford category

2 5 (17)

3 24 (80)

4 1 (3)

Smoking history 30 (100)

Diabetes mellitus 6 (20)

Hypertension 23 (77)

Hyperlipidemia 22 (73)

Coronary artery disease 10 (33)

TASC II Classification

A 7 (23)

B 9 (30)

C 14 (47)

D 0

13Moderate to severe calcification in 14 (47%) patients

Procedural and short-term results (N=30 patients)

14

Lesions 43 (14 EIA)

Devices successfully

delivered/implanted100% (49 devices)

Mean lesion length 31.6 mm

Mean stented length 50.1 mm

Contralateral delivery 8 patients (27%)

Kissing stent placement 10 patients (33%)

Acute procedural success

100%(no > 30% residual stenosis)

Primary Endpoint: 0%

(composite of device or procedure-

related death, myocardial infarction,

or amputation in the treated leg

within 30 days of the index

procedure)

Follow-up

15

Follow-up Visit Evaluations

30 days ABI; Rutherford; Iliac Duplex

9 months* ABI; Rutherford; Iliac Duplex

12 months ABI; Rutherford; Iliac Duplex

24 months ABI; Rutherford: Iliac Duplex (if indicated)

36 months ABI; Rutherford: Iliac Duplex (if indicated)

* FDA required patency reported @ 9 months

12 month follow-up results

• 96.6% primary patency (per-subject):

– 1 patient with edge stenosis at 7 months, managed with angioplasty and stenting

• Resting ABI improved from a mean 0.79 pre-procedure to 0.95 (p=<0.001)

• Rutherford category:

– 0: 50%

– 1: 20%

– 2: 23.3%

– 3: 3.3%

16

96.6% 12 month

primary patency

1 patient expired at 6 months due to acute MI not deemed procedure- or device-related

Interim 24 month analysis

• 28 patients ongoing in study at 24 months

– 1 further edge stenosis > 50% diameter loss detected on 2 year

US (day 723) – no TLR as yet

– 0 TLR from 12 to 24 months

17

• Primary patency @ 2 years 93%

• Freedom from TLR @ 2 years 97%months

Simple Reconstruction

Moderate Calcification

Simple Reconstruction

Simple Reconstruction

Complex Case Example

• 68 year old male

• Bilateral thigh and calf claudication

• Severely atheromatous aorto-iliac arteries

• RCIA CTO, LCIA stenosis

Performed as a Live case at VIVA 2014

21

Complex Case Example

22

Conservative Pre-dilatation (Severe Calcification)

23Pre-dilatation with plain balloon angioplasty in 5 patients (16.7%)

stent graft stent graft

Stent Deployment (Ends to Middle)

24

25

Labeled device diameter (mm)

Max Endoprosthesis

expanded diameter (mm)

5 8

6 8

7 11

8 11

9 13

10 13

Stent Post-dilatation

26

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.

stent graft stent graft

Complex Case Example

27

Complex Case Example

28

Delivery across the aortic bifurcation:

Flexibility and Deliverability are key features

In 8 patients (26.7%) the lesion was treated from the contralateral CFA approach

VBX FLEX – US IDE Trial

• Primary Objective: Evaluate the safety and efficacy of the

GORE® VIABAHN® Balloon Expandable Endoprosthesis for

the treatment of arterial occlusive disease in patients with

de novo or restenotic lesions in the common and/or

external iliac arteries

• Study Design: Prospective, multi-center, non-randomized,

single-arm clinical study. Rutherford categories 2-4

• 134 patients enrolled across 27 sites

• All patients have reached 9 month primary patency

endpoint

• Study results submitted for publication

30

Treated Limb(s)

Right 22.1%

Left 28.6%

Bilateral 49.3%

Kissing Stent

Procedure85.5%

TASC II

Classification

Type A 36.4%

Type B 32.1%

Type C 23.6%

Type D 7.9%

Disease

Characterization

Stenosis 87.7%

Occlusion 12.3%

VBX FLEX – US IDE Trial

Conclusions

GORE® VIABAHN® BX Endoprosthesis was designed to

meet the clinical need for a flexible and conformable balloon

expandable stent graft

• The FIH study has also shown accurate placement, minimal

foreshortening, an ability to post-dilate and high radial

resistive force to manage calcific iliac artery disease

• One and 2 year patency is excellent

• Results from the larger VBX FLEX US IDE Trial are

imminent

32

Andrew Holden, MBChB, FRANZCR

GORE® VIABAHN® BX Endoprosthesis

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.

A New More Conformable Covered Stent From GORE®:

Advantages, Limitations and Clinical Results

AnAlternativeTreatmentOptionforCalcifiedLesionsintheIliac

Arteries

AndrewHolden

AucklandHospital

Auckland,NewZealand

LINC2017– January24th 2017