Stellarex Drug-coated 0.014" angioplasty balloon

Stellarex

Drug-coated 0.014" angioplasty balloon

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Stellarex’s unique coating composition, EnduraCoat technology, combines amorphous and small-to-large crystalline paclitaxel with polyethylene glycol (PEG) excipient. EnduraCoat provides efficient drug transfer, effective tissue residency, high coating durability and minimal particulate loss.¹,²,³,⁴

Kenmerken
Calcium can be beat
Calcium can be beat

Calcium can be beat

Stellarex is the only DCB reported to have durable patency at 2 years in severely calcified lesions, showing patients with severe calcium can have a meaningful treatment effect with Stellarex. • 67.8% two-year patency in severely calcified lesions • Demonstrates a robust treatment effect over PTA in severely calcified lesions1 • 82% of severely calcified segments are =5cm long4
Effective low drug dose matters
Effective low drug dose matters

Effective low drug dose matters

Dose excess and particulate downstream possibly results in a delay of wound healing, loss of microcirculation and creation of aneurysms. Stellarex is the only low dose DCB with a statistically significant treatment effect at two years.
Treatment that endures even in complex patients
Treatment that endures even in complex patients

Treatment that endures even in complex patients

Stellarex exhibits consistent two-year patency across trials - even in the most complex cases. Now, all patients can experience the power of proven results: • 72.1% patency in ILLUMENATE Pivotal proves only durable two-year RCT results in complex lesions • 43.9% severe calcium is four or five times the rate of severe calcium studied in competitive trials⁴
The smart treatment choice for today’s PAD patients
The smart treatment choice for today’s PAD patients

The smart treatment choice for today’s PAD patients

The prevalence of calcified lesions increases with age and diabetes.5 Shown to work in calcium, Stellarex is the clear treatment choice for PAD.
Pay for the DCB that works in calcium
Pay for the DCB that works in calcium

Pay for the DCB that works in calcium

Only Stellarex gives you confidence that your DCB use and spend in severely calcified lesions will be worthwhile and beneficial to patients.
More ease of use, more efficiencies
More ease of use, more efficiencies

More ease of use, more efficiencies

Stellarex enhances time savings—even in challenging anatomies and through (or across) previously deployed stents. Decide on the DCB designed for ease of use, and feel the difference in your hands.
Differentiated technology: next-generation EnduraCoat
Differentiated technology: next-generation EnduraCoat

Differentiated technology: next-generation EnduraCoat

Stellarex EnduraCoat was designed for performance in complex and severely calcified lesions and patients with multiple comorbidities. • Hybrid paclitaxel offers prompt drug transfer and sustained tissue residency through 28 day restenotic window12 • Excipient polyethylene glycol (PEG) offers excellent adhesion and durability to protect low dose paclitaxel11 • Reduces drug loss during transit, relieving clinicians of transit time requirements8,10
Designed for performance in calcium
Designed for performance in calcium

Designed for performance in calcium

PEG forms strong ionic bonds with hydroxyl apatite (HAp), the primary component of calcified atherosclerotic lesions.1 PEG’s affinity for HAp may result in limited PTX washout in the presence of calcium. PEG may protect PTX, giving it time to be absorbed into vessel when calcium is present.
Treatment that endures even in complex patients

Treatment that endures even in complex patients

Stellarex exhibits consistent two-year patency across trials - even in the most complex cases. Now, all patients can experience the power of proven results: • 72.1% patency in ILLUMENATE Pivotal proves only durable two-year RCT results in complex lesions • 43.9% severe calcium is four or five times the rate of severe calcium studied in competitive trials4
  • Calcium can be beat
  • Effective low drug dose matters
  • Treatment that endures even in complex patients
  • The smart treatment choice for today’s PAD patients
See all features
Calcium can be beat
Calcium can be beat

Calcium can be beat

Stellarex is the only DCB reported to have durable patency at 2 years in severely calcified lesions, showing patients with severe calcium can have a meaningful treatment effect with Stellarex. • 67.8% two-year patency in severely calcified lesions • Demonstrates a robust treatment effect over PTA in severely calcified lesions1 • 82% of severely calcified segments are =5cm long4
Effective low drug dose matters
Effective low drug dose matters

Effective low drug dose matters

Dose excess and particulate downstream possibly results in a delay of wound healing, loss of microcirculation and creation of aneurysms. Stellarex is the only low dose DCB with a statistically significant treatment effect at two years.
Treatment that endures even in complex patients
Treatment that endures even in complex patients

Treatment that endures even in complex patients

Stellarex exhibits consistent two-year patency across trials - even in the most complex cases. Now, all patients can experience the power of proven results: • 72.1% patency in ILLUMENATE Pivotal proves only durable two-year RCT results in complex lesions • 43.9% severe calcium is four or five times the rate of severe calcium studied in competitive trials⁴
The smart treatment choice for today’s PAD patients
The smart treatment choice for today’s PAD patients

The smart treatment choice for today’s PAD patients

The prevalence of calcified lesions increases with age and diabetes.5 Shown to work in calcium, Stellarex is the clear treatment choice for PAD.
Pay for the DCB that works in calcium
Pay for the DCB that works in calcium

Pay for the DCB that works in calcium

Only Stellarex gives you confidence that your DCB use and spend in severely calcified lesions will be worthwhile and beneficial to patients.
More ease of use, more efficiencies
More ease of use, more efficiencies

More ease of use, more efficiencies

Stellarex enhances time savings—even in challenging anatomies and through (or across) previously deployed stents. Decide on the DCB designed for ease of use, and feel the difference in your hands.
Differentiated technology: next-generation EnduraCoat
Differentiated technology: next-generation EnduraCoat

Differentiated technology: next-generation EnduraCoat

Stellarex EnduraCoat was designed for performance in complex and severely calcified lesions and patients with multiple comorbidities. • Hybrid paclitaxel offers prompt drug transfer and sustained tissue residency through 28 day restenotic window12 • Excipient polyethylene glycol (PEG) offers excellent adhesion and durability to protect low dose paclitaxel11 • Reduces drug loss during transit, relieving clinicians of transit time requirements8,10
Designed for performance in calcium
Designed for performance in calcium

Designed for performance in calcium

PEG forms strong ionic bonds with hydroxyl apatite (HAp), the primary component of calcified atherosclerotic lesions.1 PEG’s affinity for HAp may result in limited PTX washout in the presence of calcium. PEG may protect PTX, giving it time to be absorbed into vessel when calcium is present.
Treatment that endures even in complex patients

Treatment that endures even in complex patients

Stellarex exhibits consistent two-year patency across trials - even in the most complex cases. Now, all patients can experience the power of proven results: • 72.1% patency in ILLUMENATE Pivotal proves only durable two-year RCT results in complex lesions • 43.9% severe calcium is four or five times the rate of severe calcium studied in competitive trials4

Technische specificaties

Product Catalog Number AA 14SX020040090
Product Catalog Number AA 14SX020040090
Sheath Size
  • 4F
Rated Burst Pressure
  • 14 atm
Nominal Pressure
  • 8 atm
Balloon Length
  • 40mm
Shaft Length
  • 90mm
Balloon Diameter
  • 2mm
Product Catalog Number AA 14SX020040090
Product Catalog Number AA 14SX020040090
Sheath Size
  • 4F
Rated Burst Pressure
  • 14 atm
See all specifications
Product Catalog Number AA 14SX020040090
Product Catalog Number AA 14SX020040090
Sheath Size
  • 4F
Rated Burst Pressure
  • 14 atm
Nominal Pressure
  • 8 atm
Balloon Length
  • 40mm
Shaft Length
  • 90mm
Balloon Diameter
  • 2mm
  • 1. Data on file. D044595-00.
  • 2. Mark J, et al. Physical properties of polymers. Cambridge University Press. 3rd ed. 2004.
  • 3. Granada JF. Future directions, clinical applications and local drug delivery technologies. Presented at the Transcatheter Cardiovascular Therapeutics (TCT) 25th Annual Scientific Symposium; October 27-November 1, 2013; San Francisco, California. Slide 7, 15.
  • 4. Venkatasubbu GD, et al. Surface modification and paclitaxel drug delivery of folic acid modified polyethylene glycol functionalized hydroxyapatite nanoparticles. Powder Technology. 2013;235:437-442.
  • *Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country.