MAKING AN IMPACT

WHY IN.PACT™ ADMIRAL™ IS THE DCB OF CHOICE

DURABLE.
CONSISTENT.
SAFE.

IN.PACT SFA TRIAL1

AT A GLANCE

2-Year Outcomes

78.9%

PRIMARY
PATENCY

vs 50.1% PTA

9.1%

REINTERVENTION
RATE

vs 28.3% PTA

THE RIGHT DOSE

A paclitaxel dose of 3.5 µg/mm2 provides maximum patient benefits without compromising safety.

Data Sources
  1. Scheller B et al. Paclitaxel Balloon Coating, a Novel Method for Prevention and Therapy of Restenosis. Circulation. 2004; 110:810-814
  2. Speck U et al. Neointima inhibition: comparison of effectiveness of nonstent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006; 240:411-418
  3. Cremers B et al. Comparison of two different paclitaxel-coated balloon catheters in the porcine coronary restenosis model. Clin Res Cardiol. 2009; 98:325-330
  4. Cremers B et al. Drug-eluting balloon: Very short-term exposure and overlapping. Thromb Haemost. 2009; 101: 201-206
  5. 5. Rowinsky EK, Donehower RC. Paclitaxel (Taxol). N Engl J Med. 1995; 332:1004-1014
  6. Margolis J et al. Systemic nanoparticle paclitaxel (nab-Paclitaxel) for in-stent restenosis I (SNAPIST-I): A first-in-human safety and dose-finding study. Clin Cardiol. 2007; 30:165-170

Paclitaxel demonstrates a wide and stable therapeutic window with no statistically significant differences in neointimal inhibition or local toxic effects up to 10 μg/mm2.

Paclitaxel Therapeutic Window
PACLITAXEL THERAPEUTIC WINDOW
3.5 IN.PACTAdmiral µg/mm 2

IN.PACT SFA Trial

A prospective, multi-center, randomized controlled trial to assess the safety and efficacy of IN.PACT Admiral DCB vs. standard PTA

IN.PACT SFA Trial Overview

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IN.PACT SFA TRIAL OVERVIEW

Study Type Randomized, Controlled Pivotal Trial
Primary Endpoints Efficacy: Primary Patency1
Safety: Safety Composite2
Rigor + Quality Prospective, Multi-Center
Independent, Blinded Clinical Events Committee
Independent, Blinded Core Lab Adjudication
External Monitoring
# Patients 331 Total
220 DCB Arm
# Sites + Location 57
US+EU
Key Eligibility Criteria Single lesions ≤ 18cm, CTO ≤ 10cm
TASC A-C
SFA + Proximal Popliteal
No ISR, Ca++
  • Freedom from CD-TLR and DUS-derived restenosis (PSVR ≤ 2.4) at 12 months
  • Composite 30-day freedom from device- and procedure-related mortality and 12-month freedom from target limb major amputation and clinically driven TVR
Patient Population

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Baseline Patient and Procedural Characteristics
IN.PACT(n=220) PTA(n=111) p-value
Age, yrs 67.5 ± 9.5 68.0 ± 9.2 0.612
Male 65.0 (143/220) 67.6 (75/111) 0.713
Diabetes 40.5 (89/220) 48.6 (54/111) 0.161
Current smoker 38.6 (85/220) 36.0 (40/111) 0.719
ABI/TBI* 0.769 ± 0.228 0.744 ± 0.189 0.308
Lesion length, cm 8.94 ± 4.89 8.81 ± 5.12 0.815
Total occlusions** 25.8(57/221) 19.5(22/113) 0.222
Provisional stenting 7.3 (16/220) 12.6 (14/111) 0.110
Values are mean ± SD or % (n/N). *TBI allowed/used in cases of incompressible vessels in phase II. ABI= ankle-brachial index; PTA = percutaneous transluminal angioplasty; TBI = toe-brachial index. ** N = 221, referring to the number of total lesions in the study
Trial Design Level 1 Evidence

Trial Design

Level 1 Evidence
  • Randomized, controlled
  • External, blinded core lab adjudication
  • External, blinded clinical events committee
331 Total Patients

0

Total Patients

0

DCB

0

PTA

57 Total Sites, US and EU

0

Total Sites
US and EU

Patient Demographics

Smoker

Smoker

38.6%

IN.PACT

36.0%

PTA
Diabetes

Diabetes

40.5%

IN.PACT

48.6%

PTA
Avg. Lesion

Avg. Lesion Length

8.94cm

IN.PACT

8.81cm

PTA
Total Occlusion

Total Occlusion

25.8%

IN.PACT

19.5%

PTA

The Results

IN.PACT Admiral DCB demonstrates durability and continued superiority of DCB treatment effect through 2 years.

2-year Primary Patency

Primary Patency Definition

Freedom from clinically driven TLR or freedom from restenosis as determined by Duplex ultrasound peak systolic velocity ratio ≤2.4 at 12 months and reported again at 24 months. The 24-month primary patency was calculated based on Kaplan-Meier estimate.

2-year Primary Patency
78.9 % IN.PACTAdmiral
Standard PTA 50.1 %
Primary patency was significantly higher in the IN.PACT Admiral group than in the PTA group.

2-year Reintervention Rate

Reintervention Rate Definition

Reintervention adjudicated by an independent Clinical Event Committee, blinded to the assigned treatment based on any re-intervention at the target lesion due to symptoms or drop of ABI of ≥20% or >0.15 when compared to post-procedure baseline ABI/TBI.

2-year Reintervention Rate

0.0%

IN.PACT
Admiral

0.0%

Standard
PTA

Reintervention rates were significantly lower in the DCB group than in the PTA group.
IN.PACT Admiral DCB has an excellent safety profile demonstrating statistically superior outcomes relative to PTA

Safety

IN.PACT Admiral DCB has an excellent safety profile demonstrating statistically superior outcomes relative to PTA.

2-year Safety Outcomes

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2-year Safety Outcomes

IN.PACT(n=220) PTA(n=111) p-value*
Primary safety composite† 87.4% (173/198) 69.8% (74/106) <0.001
Major adverse events∞ 19.2% (38/198) 31.1% (33/106) 0.023
All-case death§ 8.1% (16/198) 0.9% (1/106) 0.008
Device- and procedure-related 0.0% (0/198) 0.0% (0/106) >0.999
Clinically-driven TVR 12.6% (25/198) 30.2% (32/106) <0.001
Target limb major amputation 0.0% (0/198) 0.0% (0/106) >0.999
Thrombosis 1.5% (3/198) 3.8% (4./106) 0.243
Values are % (n/N); *p values are based on Fisher exact test for superiority with significance level of 0.05; † Freedom from 30-day device- and procedure-related death and target limb major amputation and clinically driven TVR within 24 months; ∞Composite of death, clinically-driven TVR, target limb major amputation, and thrombosis; §No deaths were adjudicated as device- or procedure-related by the Clinical Events Committee (CEC); Median post-index days to death: 564.5 days in DCB versus 397 days in PTA

IN.PACT SFA Trial

Primary Safety Composite

Primary Safety Composite Definition

Freedom from 30-day device- and procedure-related death and target limb major amputation and clinically driven TVR at 12 months and reported again at 24 months.

87.4%

69.8% PTA

Device- or Procedure-related Death

0.0%

0.0% PTA

Target Limb Major Amputation

0.0%

0.0% PTA

Thrombosis

1.5%

3.8% PTA

The Cost Effective Solution

The costs saved from the reduced rates of reintervention and higher rates of clinical efficacy make IN.PACT Admiral DCB the clear choice for patients and physicians.

~$1,200

Average saved on follow-up costs through two years per patient with IN.PACT Admiral2

$0

IN.PACT ADMIRAL DCB

$0

Standard PTA

Peripheral
Artery Disease
by the Numbers

of

Cases

May be asymptomatic. This leads to underdiagnosis and undertreatment of the disease.4

202million

individuals worldwide are affected by Peripheral Artery Disease (PAD).3

$0

billion

is the estimated economic burden of PAD within the US. Alternatives to PTAs, such as DCBs, can significantly reduce this cost.5

8 MILLION PATIENTS SUFFERING FROM PAD IN THE US ARE POTENTIAL CANDIDATES FOR TREATMENT OF DCBs LIKE THE IN.PACT ADMIRAL.6