Christian Wissgott MD, PhD Assistant Director, Radiology Westküstenkliniken Heide

Transcription

1 2-Year Results Of The Tack Optimized Balloon Angioplasty (TOBA) Trial For Fem- Pop Lesions Demonstrates Safety and Efficacy Of The Tack Endovascular System In Repairing Focal Post-PTA Dissections Christian Wissgott MD, PhD Assistant Director, Radiology Westküstenkliniken Heide

2 Challenges with Angioplasty & Stents POBA/DCB Dissections can cause acute stenosis and/or thrombosis DCB can also cause dissection, especially in challenging lesions (CTO, lesions > 15cm) Stenting In-stent restenosis from chronic inflammation Limited future treatment options Occasional fracture Study PACIFIER THUNDER 56% LEVANT 2 Lutonix Global Registry IN.PACT Global Registry Dissection Rate 47.4% PTA 73.5% DCB 72.3% PTA 63.7% DCB 34.3%: lesions mm (35.7% stent rate) 62%: lesions 15cm (40.4% stent rate) Zilver Zilver PTX Supera (SUPERB) SMART (SIROCCO) Stent/Study EverFlex (Durability) LifeStent (Resilient) Luminexx (FAST) Dynalink-E (STRIDES) ISR Rate 1yr 1yr 1yr 6m 1yr 1yr 1yr 1yr Metzger C, TCT 2016 Scheinert D, VIVA 2016 Lutonix is a registered trademark of Bard IN.PACT and Admiral are trademarks of Medtronic

3 Dissections Are Worse Than We Think TOBA: Baseline Dissection Grade 80 % OF SUBJECTS A Site Core Lab B C BASELINE DISSECTION GRADE Major disparity between site-reported and core lab dissection grade D E None Bosiers M et al. J Vasc Surg 2016;64(1):

4 Novel Implant Design Tack Endovascular System 1.5 Six self-expanding nitinol implants on one system ~6mm deployed implant length Each implant treats vessel diameter range 2.5mm to 6.0mm Unique anchors to minimize migration RO markers for visibility High-Precision Delivery System 6Fr catheter 80, 120 or 135cm working length over-the-wire delivery High accuracy implant deployment (within ~1mm) CAUTION: Investigational device. Tack Endovascular System is limited by Federal (United States) law to investigational use. Not approved for sale in the United States. Tack Endovascular System is CE Mark authorized under EC Directive 93/42/EEC. Tack Endovascular System and Tack are registered trademarks of Intact Vascular, Inc.

5 Designed for Better Dissection Healing Typical stent Typical Stent 6Fr Tack implant 4Fr Tack implant 6Fr Tack Implant 4Fr Tack Implant Minimal Metal 70-80% less metal vs. stenting 1 Low Radial Force Minimizes vessel trauma Focal Treatment Treat only where needed Adaptive Diameter Simplifies Procedure and Reduces Inventory Maintains Normal Vessel Biomechanics Preserves Future Treatment Options 1 Schneider PA et al. J Am Coll Cardiol Interv 2015;8(2):

6 Baseline TOBA Case Study Post-PTA Dissection (Grade C*) Final Procedure: 48 min Fluoro Time: 15 min Contrast: 100 ml *Dissection grades adjudicated by core laboratory TOBA: Tack Optimized Balloon Angioplasty

7 TOBA Study Design Design Objective Intended Use Primary Endpoints Safety Device Technical Success Prospective, single-arm, multi-center confirmatory trial for optimization of tissue apposition in peripheral arteries with Reference Vessel Diameters (RVD) ranging in diameter from 2.5 mm to 5.5 mm. Collect confirmatory data in support of the safety and performance of the Intact Vascular Tack Endovascular System The Tack Endovascular System 1.0 is indicated for tissue apposition to optimize angioplasty in peripheral arteries 2.5 mm to 5.5 mm* in diameter. It is designed to treat dissection, tissue flaps or an irregular luminal surface. Composite of new-onset major device-related adverse event(s) including device embolization, need for emergency surgical revascularization, index limb amputation (above the ankle), or CD-TLR at 30 days. The ability of the Tack to resolve post-pta dissection, tissue flaps or irregular luminal surface which demonstrates that the artery at the Tack(s) location of the Tack implant remains patent at the end of the procedure (<30% residual stenosis by completion angiogram). *The current Tack Endovascular System 1.5 is intended for use in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) type(s) A through F

8 Subject Disposition Enrollment 12-Month Follow-Up 24-Month Follow-Up TOBA 132 Subjects 122 Subjects 39 Subjects WKK 16 Subjects 16 Subjects 12 Subjects *The 24M population is a subset of the original population with no prior non-patency or TLRs as of 12M follow-up and who consented to be followed-up at 24M.

9 Patient and Lesion Characteristics Key Inclusion Criteria Rutherford 2 4 ABI 0.90 RVD mm Target lesion 10 cm Patient Characteristics All Subjects (N = 130) WKK (N = 16) Age (Y) 68.1 ± ± 8.3 Male Gender 66.9% 56.2% Diabetes 28.5% 25% Hypertension 77.7% 75% Smoking: Rutherford: Current Remote Key Exclusion Criteria Previous stent Severe calcium Untreated inflow 43.0% 72.3% 21% 74% 5% 53.8% 6.3% 31% 50% 25% Target Limb ABI 0.68 ± 0.2 NA Core Lab Baseline Lesion Characteristics (All Subjects) WKK Lesion Length (mm) 52.7 ± ± 26.4 Total Occlusion 34.4% 37.5% Dissection Grade C and Higher Lesion Location: Calcification: Proximal SFA Mid SFA Distal SFA Proximal Popliteal Mid Popliteal None/mild Moderate Severe 74.0% 62.3% 14.6% 44.6% 31.5% 7.7% 0.8% 34.1% 60.5% 5.4% 12.5% 31.3% 37.5% 18.8% 0.0% 50.% 50.% 0.0%

10 30-Day Safety and Efficacy Subjects (N=126) Major Adverse Events 0 Tack Embolization 0 Emergent Revascularization 0 Target Lesion Revascularization 0 Major Amputation 0 0.0% MAEs 98.5% Technical Success Rate (only 2 out of 130 received bailout stents) Bosiers M et al. J Vasc Surg 2016;64(1):

11 80% Improvement in ABI and Rutherford Improvement in Ankle-Brachial Index (P <0.001) Improvement in Rutherford Clinical Category Baseline 12M Δ N ABI 0.68 ± ± ± 0.21 % Change 38% % Of Subjects 70% 60% 50% 40% 30% 20% Significant Improvement 10% 0% RCC0 RCC1 RCC2 RCC3 RCC4 RCC5 Baseline 12 Months Bosiers M et al. J Vasc Surg 2016;64(1):

12 TOBA 12-Month Patency Across ALL Sites 6-Month Patency = 79.3% 12-Month Patency = 76.4% Reported Range for 12-Month Patency for POBA Alone 12-Month Freedom from TLR = 89.5% Bosiers M et al. J Vasc Surg 2016;64(1):

13 Single-Center 24-Month Patency Westküstenkliniken, Heide, Germany Patency M Patency 93.8% 12M Patency 87.5% NO loss of patency between 12 and 24 months 24M Patency 87.5% Days from Index Procedure

14 Cost Effectiveness of the Tack Implant Comparative analysis is underway Dissection repair with Tack implant versus current therapy (PTA/stenting) Expected drivers of health-economic value: Reduced TLR rates in previously unstented lesions (A/B dissections) Lower device utilization compared to stenting (6 Tack implants on one device allow treatment of multiple or long dissections) Provides more treatment options for reintervention

15 TOBA Takeaways Tack Endovascular System offers new paradigm in treating post-pta dissections Ideal adjunct to POBA and DCB angioplasty Minimal metal footprint Preserves future treatment options Rigorous clinical development program both above and below the knee Enrollment complete: ATK trial with POBA and Lutonix DCB Currently enrolling: ATK trial with IN.PACT Admiral Currently enrolling: BTK trial with POBA