Stellarex Clinical Evidence

Stellarex has demonstrated consistently high patency rates and safety in a wide range of patients across multiple clinical trials.

Top-Tier Patency in Common-to-Complex Patient Populations

Stellarex achieves the highest 1 year patency (89.0%) of any DCB in patients with similar characteristics, and top-tier patency in the most complex patient set studied in a DCB RCT, including the highest rates of severely calcified lesions.

  • Common Patients
  • Complex Patients
  • 2-year OUTCOMES
    Kaplan Meier
  • 2-year OUTCOMES
    Exact Rates
1 Year Primary Patency Rate
0%
25%
50%
75%
100%
Common Patients
89.0%
12.7%
Severe
CA++
ILLUMENATE
EU RCT2
N = 222
Stellarex
2µg/mm2
86.6%
8.1%
Severe
CA++
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
73.5%
10.4%
Severe
CA++
LEVANT 25
N = 316

Lutonix®
2µg/mm2
  • 89% patency in patients with similar characteristics—the highest patency of any DCB RCT2
  • 43% less drug dose than In.Pact4
2-year OUTCOMES
Kaplan Meier
81.4%
40.8%
Severe
CA++
ILLUMENATE
GLOBAL6
N = 220
Stellarex
2µg/mm2
82.3%
43.9%
Severe
CA++
ILLUMENATE
PIVOTAL1
N = 200
  • 82.3% patency in the highest rate of reported severely calcified lesions (43.9%)1
  • GLOBAL also shows strong patency in high rates of severe calcium6
Common Patients
75.2%
@ day 730
ILLUMENATE
EU RCT14
N = 222
Stellarex
2µg/mm2
78.9%
@ day 720
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
58.9%
@ day 730
LEVANT 215
N = 316

Lutonix®
2µg/mm2
  • 75.2% durable primary patency through 2 years per Kaplan Meier estimate
2-year OUTCOMES
Exact Rates
75.9%
@ day 790
ILLUMENATE
EU RCT14
N = 222
Stellarex
2µg/mm2
69.2%
@ day 750
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
53.8%
@ day 790
LEVANT 215
N = 316

Lutonix®
2µg/mm2
  • 75.9% durable patency through 2 years per exact rates

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Proven in Complex Patients and Comorbidities

The true measure of Stellarex performance is its top-tier patency in challenging lesions and comorbidities, including severe calcium, diabetic patients, renal insufficiency, female patients and clinically obese patients. In addition, Stellarex is the only DCB proven effective in the highest rates of severe calcium in an RCT.

  • SEVERE CA++
  • DIABETIC
  • Renal Insufficiency
  • Clinically Obese
  • Female
% of Patients
0%
20%
40%
60%
SEVERE
CA++
43.9%
ILLUMENATE
PIVOTAL1
N = 200
Stellarex
2µg/mm2
12.7%
ILLUMENATE
EU RCT2
N = 222
8.1%
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
10.4%
LEVANT 25
N = 316

Lutonix®
2µg/mm2
  • Stellarex studied in 4–5 times the rate of severe calcium than in competitive DCB RCT trials
  • 43.9% of patients in Stellarex ILLUMENATE PIVOTAL trial had severe calcium—the highest of any DCB RCT1
  • Only 8.1% of patients in In.Pact SFA and 10.4% of patients in LEVANT 2 had severe calcium4,5
DIABETIC
49.5%
ILLUMENATE
PIVOTAL1
N = 200
Stellarex
2µg/mm2
37.4%
ILLUMENATE
EU RCT2
N = 222
40.5%
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
43.4%
LEVANT 25
N = 316

Lutonix®
2µg/mm2
  • 49.5% diabetic patients—highest rate of any DCB RCT1
  • Smaller vessels, more torturous anatomies
  • Increased incidence of vascular calcifications
  • Occlusions more prevalent than stenoses
Renal
Insufficiency
18%
ILLUMENATE
PIVOTAL1
N = 200
Stellarex
2µg/mm2
9%
ILLUMENATE
EU RCT2
N = 222
8.3%
IN.PACT SFA
N = 2004

In.Pact
3.5µg/mm2
3.3%
LEVANT 2
N = 3165

Lutonix®
2µg/mm2
  • 18% of patients with renal insufficiency—highest rate of any DCB RCT1
  • Rapid disease progression
  • Decreased clinical efficacy after SFA intervention
Clinically
Obese
39.5%
ILLUMENATE
PIVOTAL1
N = 200
Stellarex
2µg/mm2
24.8%
ILLUMENATE
EU RCT2
N = 222
27.7%
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
34.8%
LEVANT 25
N = 316

Lutonix®
2µg/mm2
  • 39.5% clinically obese patients—highest rate of any DCB RCT1
  • BMI >30 = clinically obese
Female
44%
ILLUMENATE
PIVOTAL1
N = 200
Stellarex
2µg/mm2
27.9%
ILLUMENATE
EU RCT2
N = 222
35%
IN.PACT SFA4
N = 200

In.Pact
3.5µg/mm2
38.9%
LEVANT 25
N = 316

Lutonix®
2µg/mm2
  • 44% female patients—highest rate of any DCB RCT1
  • Smaller vessels
  • Lutonix patency in females was 4.9% less effective than PTA5
“The Stellarex DCB has shown safety and efficacy in a cohort of patients, which included a higher preponderance of diabetics and core-lab defined severely calcified lesions in the US IDE trial. These results, in combination with the cohort of patients studied in the EU RCT, demonstrate that the Stellarex DCB is safe and effective in diverse patient populations when addressing symptomatic femoropopliteal disease. ”
Professor Thomas Zeller, MD

Low Clinically Driven Target Lesion Revascularization (CD-TLR)

Consistently low CD-TLR rates demonstrate the safety of Stellarex in common-to-complex patients.

 

Significant treatment effect observed out to 2 years and increasing from 1 to 2 years.

  • Complex Patients
  • 2-year Treatment Effect
CD-TLR Rate
0%
5%
10%
15%
20%
25%
30%
35%
Complex Patients
7.9%
ILLUMENATE
PIVOTAL1
N = 200
Stellarex
16.8%
ILLUMENATE
PIVOTAL1
N = 100
PTA
  • Treatment effect over PTA 8.9% in complex patients1
2-year Treatment Effect
1 year
5.9%
ILLUMENATE
EU RCT2
N = 222
Stellarex
16.7%
△ 10.8%
P = 0.014
ILLUMENATE
EU RCT2
N = 78
PTA
2 year
12.1%
ILLUMENATE
EU RCT14
N = 222
Stellarex
30.5%
△ 18.4%
P < 0.001
ILLUMENATE
EU RCT14
N = 78
PTA
  • Treatment effect over PTA increased from 10.8% in year 12 to 18.4% in year 214
  • Proves Stellarex durability at 2 years14
  • 60% fewer revascularizations than PTA

Robust ILLUMENATE Clinical Trial Series

Stellarex is the only commercially available DCB for the SFA with two reported randomized controlled trials, four clinical trials (N = 1,079)6 and the largest number of randomized patients (N = 628)6. Across clinical trials, Stellarex delivers consistent results.

Illumenate Study atk

“Stellarex is the first low-dose DCB to demonstrate a significant treatment effect at 2 years. ”
Marianne Brodmann, MD
Stellarex DCB Ballon

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