FLEXIBLE, BALOON EXPANDABLE
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1 EARLY RESULTS OF A CLINICAL TRIAL OF FLEXIBLE, BALOON EXPANDABLE COVERED STENT GRAFT IN ILIAC OCCLUSIVE DISEASE Chris LeCroy Coastal Vascular and Interventional Pensacola, Florida
2 Clinical Trial WL GORE VBX Flex stent graft system Trial Results Where does this technology fit in?
3 Iliac Occlusive Disease A large amount of PAD involves the iliac arteries Stenting is effective primary therapy for iliac artery stenosis and occlusions* *Anderson, IL, et al Circulation :27(13)
4 Iliac Occlusive Disease Randomized, prospective study demonstrated improved patency with balloon expandable stent grafts over bare metal stents in complex iliac lesions* Society guidelines recommend stent grafts in instances of severe calcification at risk of vessel rupture** *Mwipatayi, et al JVS (6) **SVS lower extremity guidelines writing group, JVS (3)
5 Iliac Treatment Challenges Tortuous anatomy High grade stenosis / occlusion Noncompliant calcified artery at risk of rupture Impermeable graft material High radial strength Ostial lesions Accurate stent graft deployment Tapered vessel Adjustable sent graft diameter Native vessel tortuosity / mobility Requires stent graft conformability
6 Iliac Treatment Challenges Current stent graft technology Covered stent / good radial force Rigid deployment system difficulty in delivery to some targets Inflexible once deployed limitation in many anatomical regions Study device Covered stent graft High radial force once deployed Flexible deployment system delivery to almost any target Maintains excellent conformability and flexibility once deployed Significant advantage in tortuous / mobile target lesions
7 Device Technology Highly flexible stent and catheter Semi compliant balloon
8 VBX Stent Graft Technology GORE, VIABAHN, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
9 Configurations
10 Study Overview
11 Baseline Characteristics VBX FLEX Study Procedural Characteristics
12 Procedural Results 100% restoration of lumen diameter 30% residual stenosis due to high radial strength, even in highly calcified and non-compliant lesions 100% stent delivery All devices successfully delivered to and deployed at target site with no stent dislodgement 100% maintenance of stent length Median length change 0 mm, pre-deployed to final implant 97% acute procedural success 4 subjects with procedural-related serious adverse events that successfully resolved
13 Clinical Endpoints at Nine Months VBX FLEX
14 VBX Stent Graft Performance GORE, VIABAHN, and designs are trademarks of W. L. Gore & Associates W. L. Gore & Associates, Inc.
15 Flexible Strength Case Study (Holden 1 ) The Challenge (A) High-grade focal left external iliac artery stenosis The Procedure (B) VBX is deployed across the aortic bifurcation from the right common femoral artery The Result (C) Completion angiography show no residual stenosis 1. Holden A., Merrilees S., Buckley B., et al. First-in-human experience with the Gore balloon-expandable covered endoprosthesis in iliac artery occlusive disease. Journal of Endovascular Therapy 2016; 24(1);
16 Complex Bifurcation Case Study (Holden 1 ) The Challenge (A) Complex bilateral common iliac artery stenosis The Procedure (B) VBX is deployed in a kissing fashion to reconstruct the aortic bifurcation Note the severe arterial calcification (arrows) The Result (C, D) Completion retrograde angiography show widely patent iliac arteries VBX conforms to native vessel tortuosity 1. Holden A., Merrilees S., Buckley B., et al. First-in-human experience with the Gore balloon-expandable covered endoprosthesis in iliac artery occlusive disease. Journal of Endovascular Therapy 2016; 24(1);
17 VBX FLEX STUDY CONCLUSIONS
18 Technology Stent Graft technology works well Excellent results Flexible even post deployment allows for expansion of anatomic treatment regions External iliac
19 Unmet Need Stent graft deployment / delivery system Highly flexible Expanded anatomic territories for treatment Tortuous vessels Contralateral deployment Semi-compliant balloon Conformability / tailoring diameter to target vessel (even areas in same lesion) High degree of radial force Calcified lesions Embolic material coverage Vessel rupture protection
20 Conclusion Excellent technology Fills unmet needs in iliac occlusive disease Future directions Iliac Visceral / renal Hemodialysis access Branched / fenestrated EVAR and TEVAR
21 THANK YOU!
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