Tack Optimized Balloon Angioplasty. George Adams, MD, MHS, FACC, FSCAI University of North Carolina Rex Healthcare Raleigh, North Carolina, USA

Transcription

1 Tack Optimized Balloon Angioplasty George Adams, MD, MHS, FACC, FSCAI University of North Carolina Rex Healthcare Raleigh, North Carolina, USA

2 Dissections Occur Frequently Dissection is a result of plaque disruption during angioplasty DCB may not be a stand-alone 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) 26.2% 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

3 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):

4 Stents Have 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 Limit future treatment options Fracture Luminexx (FAST) 1yr 1yr Dynalikn-E (STRIDES) 1yr 1 yr

5 Tack Endovascular System Tack Implant Unique anchoring minimizes migration Delivery System Pin-and-pull delivery technique Nitinol with gold radiopaque markers Sizing: 4F 1.5mm-4.5mm RVD 6F 2.5mm-6mm RVD 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 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.

6 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 1 Schneider PA et al. JACC Cardiovasc Interv 8(2):

7 Evidence Study Design Status Key Findings TOBA (N=138) TOBA II (N=210) TOBA III (N=200) Prospective, single arm 13 European sites Prospective, single arm 40 US and European sites Prospective, single arm 20 European sites Long lesion subset ( 250 mm) 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 Enrolling Enrolling Actively enrolling POBA or Lutonix DCB Actively enrolling IN.PACT Admiral DCB Bosiers M et al. J Vasc Surg 64(1):

8 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)

9 Challenges in BTK Treatment It s a different disease Small vessel diameters Diffuse calcium with poor treatment options PTA POBA, DCB Poor long-term outcomes Dissection Stents BMS, DES In-stent restenosis Alternatives Atherectomy Invasive bypass surgery

10 Evidence Study Design Status Key Findings TOBA BTK (N=35) BTK - Prospective, single arm 6 Europe/New Zealand 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):

11 TOBA BTK Demographics and Lesion Characteristics Subjects Safety (n=35) Performance (n=32) Age (Y) 76.1 ± ± 9.5 Gender: Female Male 48.6% 51.4% 43.8% 56.3% Diabetes 77.1% 81.3% Hypertension 91.4% 90.6% Smoking: Current Remote Rutherford: % 29.4% 11.4% 88.6% ~90% were Rutherford 5 ~80% had diabetes 6.5% 32.3% 12.5% 87.5% Core Lab Baseline Lesion Characteristics (Safety Sample) Lesion length (mm) 51.4 ± 28.0 (34) Total occlusion 22.2% (8/36) Dissection Grade: A B C Proximal Lesion Location: Anterior tibial Tibioperoneal trunk Peroneal Posterior tibial Calcification: None/mild Moderate Severe 21.2% (7/33) 60.6% (20/33) 18.2% (6/33) 38.9% (14/36) 27.8% (10/36) 16.7% (6/36) 16.7% (6/36) 36.1% (13/36) 61.1% (22/36) 2.8% (1/36) Broad anatomical distribution >60% moderate/severe calcification 1/5 th of patients had total occlusions Lesion lengths up to 8cm ~80% Grade B+ dissections

12 Safety and Performance Parameter Safety Sample N=35 Performance Sample; N=32 Device Success 1 32/35 (91.4%) NA Procedure Success 2 34/35 (97.1%) 31/32 (96.9%) 1 Successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter 2 Demonstrated vessel patency as reported by the physician (visual estimate) without the occurrence of MALE + POD on the date of procedure Primary Safety at 30 Days Safety Sample Perf. Sample Composite Primary Safety Endpoint 1/35 (2.9%) 1/32 (3.1%) Major Amputation 0/35 (0.0%) 0/32 (0.0%) Re-intervention 1/35 (2.9%) 1/32 (3.1%) Death 0/35 (0.0%) 0/32 (0.0%)

13 Twelve-month Results Primary Patency 100 Primary Patency by Vessel at 12m = 78.4% Primary Patency Per Patient Primary Patency by Subject at 12m = 77.4% Days Since Index Procedure Days Since Index Procedure Observational Endpoint 30 Days 3 Months 6 Months 12 Months Amputation-free survival (above the ankle) 100% 96.8% 96.8% 84.5% Freedom from CD-TVR 100% 100% 93.5% 93.5% Freedom from CD-TLR 100% 100% 93.5% 93.5%

14 TOBA II BTK What s Next? Pivotal study of the Tack device in the treatment of patients with critical limb ischemia Study Design Prospective, single-arm, multi-center Population Subjects with CLI (RCC 3-5) and angiographic evidence of a dissection post-pta Patients will be assessed using the WIfI risk stratification system No lesion length maximum Subjects/Sites 232 subjects at up to 50 global sites (~40 US sites)

15 TOBA II BTK Primary Endpoints Safety Efficacy Secondary Endpoints MALE + POD at 30 days MALE at 12 months + POD at 30 days Target lesion(s) tacked segment(s) patency at 12 months defined as the presence of blood flow using duplex ultrasound (flow vs. no flow) Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 12 months Enrollment to begin Q Enrollment projected to be complete in Q1 2019

16 Summary Tack Endovascular System offers new paradigm in treating post-pta dissections Preserves future treatment options Rigorous clinical development program both above and below the knee

17 Tack Optimized Balloon Angioplasty George Adams, MD, MHS, FACC, FSCAI University of North Carolina Rex Healthcare Raleigh, North Carolina, USA