TOBA II and TOBA III Clinical Programme Updates

Transcription

1 TOBA II and TOBA III Clinical Programme Updates Michael K. W. Lichtenberg MD, FESC Vascular Center Arnsberg, Germany

2 Conflict of Interest - Disclosure Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company 1. Honoraria for lectures: CR Bard, Veniti, AB Medica, Volcano, Optimed GmbH, Straub Medical, Terumo, Biotronik, Veryan 2. Honoraria for advisory board activities: Veniti, Optimed GmbH, Straub Medical, Biotronik, Veryan, Boston Scientific 3. Participation in clinical trials: Biotronik, CR Bard, Veryan, Straub Medical, Veniti, TVA Medical, Boston Scientific, LimFlow 4. Research funding: Biotronik, Boston Scientific, Veryan, Veniti, AB Medica

3 Dissections Occur Frequently Dissection is a result of plaque disruption during angioplasty DCB is not a standalone therapy in mechanically challenging SFA/popliteal lesions: CTO Lesions >15 cm Study PACIFIER THUNDER 56% LEVANT 2 DCB Registry Lutonix Global Registry 1 IN.PACT Global Registry 1 Dissection Rate 47.4% PTA 73.5% DCB 72.3% PTA 63.7% DCB Dissection/Stent Rate 34.3% in lesions mm (35.7% stent rate) 62% in lesions 15cm (40.4% stent rate) Metzger C. Multicenter Global Registry Report of the Two-year Outcomes with a Paclitaxel-Coated Balloon in Patients with Complex Femoropopliteal Lesions, TCT 2016 Scheinert D. Strengths and Weakness of DCBs: Insights from the Global Registries, VIVA 2016

4 Often Worse Than We Think TOBA: Baseline Dissection Grade A B Site Core Lab C D E None Major disparity between site reported and core lab dissection grade Bosiers M et al. J Vasc Surg 64(1):

5 Stents Have Significant Limitations Stent (study) Zilver Zilver PTX Re-stenosis 1yr 1yr Stent Fracture Rate 0.9% RCT 1.5% SAT Supera (SUPERB) 1yr 1yr Wallstent Up to 19% SMART (SIROCCO) 6m 6m EverFlex (Durability) 1yr 0.4% LifeStent (Resilient) 1yr 1yr Chronic inflammation In-stent restenosis Limited future treatment options Occasional fracture Luminexx (FAST) 1yr 1yr Dynalikn-E (STRIDES) 1yr 1 yr

6 Tack Endovascular System Tack Implant Unique anchoring minimizes migration Delivery System Pin-and-pull delivery technique Nitinol with gold radiopaque markers Designed for high-accuracy deployment Over-the-wire system Pre-loaded 6mm implants CAUTION: Investigational device. Tack Endovascular System is limited by Federal (United States) law to investigational use. Not approin the United States. Tack Endovascular System is CE Mark authorized under EC Directive 93/42/EEC. Tack Endovascular Systemved for sale and Tack are registered trademarks of Intact Vascular, Inc.

7 Better Healing 1 by Design Typical Stent 4Fr Tack Implant 6Fr Tack Implant Minimal Metal Short, open cell design 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. JACC Cardiovasc Interv 8(2):

8 Robust Clinical Development Platform Study Design Status Key Findings TOBA (N=138) Prospective, single arm 13 European sites ABOVE THE KNEE Completed Published in Journal of Vascular Surgery % K-M freedom from CD-TLR 76.4% K-M patency rate 98.5% technical success rate TOBA II (N=210) Prospective, single arm 40 US and European sites Enrolling Actively enrolling POBA or Lutonix DCB TOBA III (N=200) Prospective, single arm 20 European sites Long lesion subset ( 250 mm) Enrolling Actively enrolling IN.PACT Admiral DCB Study Design Status Key Findings TOBA BTK (N=35) TOBA II BTK (N=232) BTK - Prospective, single arm 6 Europe/New Zealand sites BTK - Prospective, single arm 50 US and global sites BELOW THE KNEE Completed Presented at SCAI % 30-day patency 84.5% amputation-free survival at 12m 93.5% freedom from CD-TLR at 12m Bosiers M et al. J Vasc Surg 64(1):

9 What will the Tack implant add to DCB patency?

10 TOBA II/TOBA III: Study Design Study Design Prospective, single-arm, multi-center Population Subjects with de novo or restenotic or occluded lesions located in the SFA and P1 arteries with RVD of 2.5 to 6.0 mm Subjects with <30% residual stenosis and evidence of dissection post-pta Sites/Subjects 40 sites in US and Europe 210 subjects 15 sites in Europe 200 subjects 170 with lesions 150mm 30 with lesions 250mm PTA Balloon POBA or Lutonix DCB IN.PACT Admiral DCB

11 TOBA II/TOBA III: Endpoints Primary Safety Endpoint: Freedom from any new-onset MAE: Index limb amputation (above the ankle) CEC adjudicated clinically-driven target lesion revascularization (CD-TLR) All-cause death at 30 days Primary Efficacy Endpoint: Primary patency: Freedom from CEC adjudicated CD-TLR Freedom from core lab-adjudicated DUS binary restenosis at 12 months (PSVR >2.5)

12 TOBA II/TOBA III: Study Updates Current Status Enrollment nearing completion CE Mark authorized under 93/42/EEC Future 12-Month Data projected for mid 2018 FDA Modular PMA Submission in process Enrollment underway Currently recruiting patients at 13 sites in Europe Enrollment completion projected for mid 2018

13 Summary Tack Endovascular System offers new paradigm in treating post-pta dissections Ideal adjunct to DCB angioplasty Rigorous clinical development program both above and below the knee Preserves future treatment options

14 TOBA II and TOBA III Clinical Programme Updates Michael K. W. Lichtenberg MD, FESC Vascular Center Arnsberg, Germany