Tack Optimized Balloon Angioplasty

George Adams, MD, MHS, FACC, FSCAIUniversity of North Carolina – Rex Healthcare

Raleigh, North Carolina, USA

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 Dissection Rate

PACIFIER 47.4% PTA73.5% DCB

THUNDER 56%

LEVANT 2 72.3% PTA63.7% DCB

Metzger C. Multicenter Global Registry Report of the Two-year Outcomes with a Paclitaxel-Coated Balloon in Patients with Complex Femoropopliteal Lesions, TCT 2016Scheinert D. Strengths and Weakness of DCBs: Insights from the Global Registries, VIVA 2016

DCB Registry Dissection/Stent Rate

Lutonix® Global Registry1

34.3% in lesions 140 – 500mm(35.7% stent rate)

IN.PACT® Global Registry1

26.2% in lesions ≥ 15cm(40.4% stent rate)

…Often Worse Than We Think

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AB

CD

ENone

TOBA: Baseline Dissection Grade

Site

Core Lab

Major disparity between site reported and core lab dissection grade

Bosiers M et al. J Vasc Surg 64(1):109-16.

• Chronic inflammation

• In-stent restenosis

• Limit future treatment options

• Fracture

Stent (study) Re-stenosisStent Fracture

Rate

ZilverZilver PTX

16% @ 1yr10% @ 1yr

0.9% RCT1.5% SAT

Supera (SUPERB) 13% @ 1yr 0.0% @ 1yr

Wallstent Up to 19%

SMART (SIROCCO) 18% @ 6m 18.2% @ 6m

EverFlex (Durability) 28% @ 1yr 0.4%

LifeStent (Resilient) 19% @ 1yr 3.1% @ 1yr

Luminexx (FAST) 32% @ 1yr 12% @ 1yr

Dynalikn-E (STRIDES) 32% @ 1yr 2% @ 1 yr

Stents Have Limitations

Tack Endovascular System®

Tack® Implant

Nitinol with gold radiopaque markers

Unique anchoring minimizes migration

Pin-and-pull delivery technique

Over-the-wire system

Pre-loaded 6mm implants

Delivery System

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.

Sizing:4F – 1.5mm-4.5mm RVD6F – 2.5mm-6mm RVD

Minimal Metal

Short, open cell design

Low Radial Force

Minimizes vessel trauma

Focal Treatment

Treat only where needed

Typical Stent

6Fr Tack Implant

4Fr Tack Implant

Better Healing1 by Design

1Schneider PA et al. JACC Cardiovasc Interv 8(2):347-54.

Evidence

Study Design Status Key Findings

TOBA(N=138)

Prospective, single arm13 European sites

Completed Published in Journal of Vascular Surgery 2016• 89.5% K-M freedom from CD-TLR• 76.4% K-M patency rate• 98.5% technical success rate

TOBA II(N=210)

Prospective, single arm40 US and European sites

Enrolling Actively enrollingPOBA or Lutonix® DCB

TOBA III(N=200)

Prospective, single arm20 European sitesLong lesion subset (≤250 mm)

Enrolling Actively enrollingIN.PACT® Admiral® DCB

ABOVE THE KNEE

Bosiers M et al. J Vasc Surg 64(1):109-16.

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)

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

Challenges in BTK Treatment

Evidence

Study Design Status Key Findings

TOBA BTK(N=35)

BTK - Prospective, single arm6 Europe/New Zealand sites

Completed Presented at SCAI 2016• 100% 30-day patency• 84.5% amputation-free survival at 12m• 93.5% freedom from CD-TLR at 12m

BELOW THE KNEE

Bosiers M et al. J Vasc Surg 64(1):109-16.

TOBA BTK Demographics and Lesion Characteristics

SubjectsSafety(n=35)

Performance(n=32)

Age (Y) 76.1 ± 9.3 76.1± 9.5

Gender:Female

Male48.6%51.4%

43.8%56.3%

Diabetes 77.1% 81.3%

Hypertension 91.4% 90.6%

Smoking:CurrentRemote

5.9%29.4%

6.5%32.3%

Rutherford:45

11.4%88.6%

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: ABC

21.2% (7/33)60.6% (20/33)18.2% (6/33)

Proximal Lesion Location:Anterior tibial

Tibioperoneal trunkPeroneal

Posterior tibial

38.9% (14/36)27.8% (10/36)16.7% (6/36)16.7% (6/36)

Calcification: None/mildModerate

Severe

36.1% (13/36)61.1% (22/36)2.8% (1/36)

• Broad anatomical distribution• >60% moderate/severe calcification• 1/5th of patients had total occlusions• Lesion lengths up to 8cm• ~80% Grade B+ dissections

• ~90% were Rutherford 5

• ~80% had diabetes

Safety and Performance

ParameterSafety Sample

N=35

Performance

Sample; N=32

Device Success1 32/35 (91.4%) NA

Procedure Success2 34/35 (97.1%) 31/32 (96.9%)

1Successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter2Demonstrated 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%)

Twelve-month Results

Days Since Index Procedure

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mary

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ncy P

er

Pati

ent

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Primary Patency by Vessel at 12m = 78.4%

Primary Patency by Subject at 12m = 77.4%P

rim

ary

Pat

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cy

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%

What’s Next?

TOBA II BTKPivotal 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)

TOBA II BTK

Primary Endpoints

Safety MALE + POD at 30 days

Efficacy MALE at 12 months + POD at 30 days

Secondary Endpoints

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 Q1 2017Enrollment projected to be complete in Q1 2019

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

Tack Optimized Balloon Angioplasty

George Adams, MD, MHS, FACC, FSCAIUniversity of North Carolina – Rex Healthcare

Raleigh, North Carolina, USA