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 top-tier 2-year patency in patients with similar characteristics, and 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 patency in
    severe calcium
2-year primary patency rate
0%
25%
50%
75%
100%
Common Patients
75.2%
@ day 730
ILLUMENATE
EU RCT18
N = 222
Stellarex
2µg/mm2
78.9%
@ day 720
In.Pact SFA34
N = 200

In.Pact
3.5µg/mm2
58.9%
@ day 730
Levant 25
N = 316

Lutonix
2µg/mm2
  • ILLUMENATE EU-RCT demonstrates top-tier patency in patients with similar rates of comorbidities and severe calcium as In.Pact SFA and Levant 2
Complex patients
72.4%
ILLUMENATE
GLOBAL36
N = 220
Stellarex
2µg/mm2
72.1%
ILLUMENATE
PIVOTAL35
N = 200
  • Only DCB RCT reporting top-tier 2-year patency in high rates of comorbidities and severe calcium
2-year patency in severe calcium
67.8%
△ 15.3%
ILLUMENATE
PIVOTAL35

Stellarex
52.5%
ILLUMENATE
PIVOTAL35

PTA
  • 67.8% 2-year patency in severely calcified lesions
  • Robust treatment effect over PTA in severely calcified lesions
  • Stellarex is the only DCB reported to have durable patency at 2 years in severely calcified lesions.
Competitor studies are independent clinical trials with different protocols and definitions. Therefore, they are not head-to-head comparisons, and data presented cannot be directly compared. Calcium definitions may vary from study to study, and the rates presented here are based on those used and reported in each respective study. Complex patients refers to high rates of severe calcium, diabetes and renal insufficiency estimates. Primary patency based on Kaplan-Meier.

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. Stellarex continues to perform in these patients through 2 years.

  • 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
  • 43.9% of patients in Stellarex ILLUMENATE PIVOTAL trial had severe calcium—the highest of any DCB RCT1
  • Stellarex studied in 4–5 times the rate of severe calcium than in competitive DCB RCT trials
  • 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
SFA4
N = 200
In.Pact
3.5µg/mm2
3.3%
Levant 25
N = 316

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
Data overview for informational purposes only and not for head-to-head comparison. Calcium definitions may vary from study to study, and the rates presented here are based on those used and reported in each respective study.
“
“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

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©2022 Koninklijke Philips N.V. September 2018

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IMPORTANT SAFETY INFORMATION

The Stellarex 0.035" OTW drug-coated angioplasty balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation of de novo or restenotic lesions up to 180mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.

The Stellarex 0.035" OTW drug-coated angioplasty balloon is contraindicated for use in:

  • Patients with known hypersensitivity to paclitaxel or structurally related compounds
  • Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy
  • Women who are breastfeeding, pregnant or are intending to become pregnant, or men intending to father children
  • Coronary arteries, renal arteries and supra-aortic/cerebrovascular arteries
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system

Possible adverse effects associated with the balloon dilation procedure include, but are not limited to: Abrupt vessel closure; Allergic reaction to contrast medium, antiplatelet therapy or catheter system components (drug, excipients and materials); Amputation/Loss of limb; Arrhythmias; Arterial aneurysm; Thrombosis; Arterio-venous  fistula (AVF); Bleeding; Death; Embolism/Device embolism; Fever; Hematoma; Hemorrhage; Hypertension/Hypotension; Infection or pain at insertion site; Inflammation; Ischemia or infarction of tissue/organ; Occlusion; Pain or tenderness; Peripheral edema; Pseudoaneurysm; Renal insufficiency or failure; Restenosis; Sepsis or systemic infection; Shock; Stroke/Cerebrovascular accident; Vessel dissection, perforation, rupture, spasm or recoil; Vessel trauma that requires surgical repair; Balloon rupture; Detachment of a component of the balloon and/or catheter system; Failure of the balloon to perform as intended; Failure to cross the lesion.

Additional complications that may be associated with the addition of paclitaxel to the balloon include, but may not be limited to the following: Allergic/Immunologic reaction to paclitaxel; Alopecia; Anemia; Gastrointestinal symptoms (diarrhea, nausea, pain, vomiting); Hematologic dyscrasia (including neutropenia, leukopenia, thrombocytopenia); Hepatic enzyme changes; Histologic changes in vessel wall including inflammation, cellular damage or necrosis; Myalgia/Arthralgia; Myelosuppression; Peripheral neuropathy.

©2018 Koninklijke Philips N.V. All rights reserved. Some or all products manufactured by Spectranetics, a Philips company. Approved for external distribution. D037951-07 092018

Caution: Federal law restricts this device to sale by or on the order of a physician