Stellarex
Drug-coated 0.035" angioplasty balloons
  • Low tip profile (0.039") and high pushability facilitate trackability and lesion crossing, even in challenging anatomies and through previously deployed stents.
  • Featuring EnduraCoat technology, provides top-tier patency to treat common-to-complex lesions with a low drug dose.

Stellarex

Drug-coated 0.035" angioplasty balloons
Stellarex drug-coated balloon featuring EnduraCoat technology comprising hybrid coating, Polyethylene glycol (PEG) excipient and 2µg/mm² low drug dose. Proven safety and efficacy in SFA.

Clinical image gallery

  • Top-tier patency and safety with the lowest effective drug dose in all SFA patients – common to complex*†
    Top-tier patency and safety with the lowest effective drug dose in all SFA patients – common to complex*†
  • Stellarex DCB has shown a consistent lack of statistical difference in mortality compared with PTA at each annual follow-up through 4 years across two randomized controlled trials⁹,¹⁷.
    Stellarex DCB has shown a consistent lack of statistical difference in mortality compared with PTA at each annual follow-up through 4 years across two randomized controlled trials⁹,¹⁷.
  • Top-tier patency and safety with the lowest effective drug dose in all SFA patients – common to complex*†
    Top-tier patency and safety with the lowest effective drug dose in all SFA patients – common to complex*†
Features
Effective low drug dose matters
Dose excess and particulate downstream possibly results in a delay of wound healing, loss of microcirculation and creation of aneurysms¹⁰⁻¹³. Stellarex is the only low dose DCB with a statistically significant treatment effect in femoropopliteal lesions².
Effective low drug dose matters
Proven performance in calcium
PEG forms strong ionic bonds with hydroxyl apatite (HAp), the primary component of calcified atherosclerotic lesions¹⁴. PEG’s affinity for HAp may result in limited PTX washout in the presence of calcium.
Proven performance in calcium
Sustained tissue Residency
Hybrid paclitaxel offers prompt drug transfer and sustained tissue residency through 28 day restenotic window¹⁵⁻¹⁶.
Sustained tissue Residency
Specifications
  • Product catalog number AB35SX040040080
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    40 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040060080
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    60 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040080080
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    80 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040100080
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    100 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040120080
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    120 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX050040080
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    40 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050060080
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    60 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050080080
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    80 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050100080
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    100 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050120080
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    120 mm
    Shaft length
    80 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    16 atm
  • Product catalog number AB35SX060040080
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    40 mm
    Shaft length
    80 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060060080
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    60 mm
    Shaft length
    80 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060080080
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    80 mm
    Shaft length
    80 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060100080
    Sheath Size
    6F
    Balloon Diameter
    6 mm
    Balloon Length
    100 mm
    Shaft Length
    80 cm
    Nominal Pressure
    8 atm
    Rated Burst Pressure
    14 atm
  • Product catalog number AB35SX060120080
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    120 mm
    Shaft length
    80 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    12 atm
  • Product catalog number AB35SX040040135
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    40 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040060135
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    60 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040080135
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    80 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040100135
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    100 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX040120135
    Sheath size
    6F
    Balloon diameter
    4 mm
    Balloon length
    120 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    20 atm
  • Product catalog number AB35SX050040135
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    40 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050060135
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    60 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050080135
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    80 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050100135
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    100 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    18 atm
  • Product catalog number AB35SX050120135
    Sheath size
    6F
    Balloon diameter
    5 mm
    Balloon length
    120 mm
    Shaft length
    135 cm
    Nominal pressure
    10 atm
    Rated burst pressure
    16 atm
  • Product catalog number AB35SX060040135
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    40 mm
    Shaft length
    135 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060060135
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    60 mm
    Shaft length
    135 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060080135
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    80 mm
    Shaft length
    135 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060100135
    Sheath size
    6F
    Balloon diameter
    6 mm
    Balloon length
    100 mm
    Shaft length
    135 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    14 atm
  • Product catalog number AB35SX060120135
    Sheath size
    6F
    Balloon length
    120 mm
    Balloon diameter
    6 mm
    Shaft length
    135 cm
    Nominal pressure
    8 atm
    Rated burst pressure
    12 atm


Documentation

Stellarex 5 year brochure
PDF|7.67 MB
Disclaimer
1. Lyden S, ILLUMENATE trial update, oral presentation, AMP Aug 2019.. 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.
2. Mathews SJ, Stellarex in the Treatment of the SFA and Popliteal: Late- Breaking 3-Year Data, oral presentation, NCVH June 2019.
3. Lyden S, Safety And Effectiveness Of The Stellarex DCB With Low Dose Paclitaxel: 4 Year Results from the ILLUMENATE Pivotal trial, oral presentation, LINC Jan 2020, Leipzig, Germany.
4. Laird, et al. J Am Coll Cardio. 2015;66:2329-2338. In.Pact Summary of Safety and Effectiveness Data (SSED). Medtronic In.Pact Instructions for Use, M052624T001 Rev 1F.
5. Bard Lutonix Instructions for Use, BAW1387400r3.
6. Holden A. Comparing Trials Data in the Management of Calcified Arteries. Charing Cross 2018. April 24-26, 2018; London, UK.
7. Gray WA, Mortality assessment of ptx coated balloons - patient-level meta-analysis of the ILLUMENATE clinical program at 3 years, Circulation, 140:1145-1155, Oct 2019 1.
8. Lyden, S. LINC, 2019. Long-term safety data from the Stellarex DCB program Jan. 22, 2019. Leipzig, Germany.
9. Lyden S, Safety And Effectiveness Of The Stellarex DCB With Low Dose Paclitaxel: 4 Year Results from the ILLUMENATE Pivotal trial, oral presentation, LINC Jan 2020, Leipzig, Germany.
10. Diamantopoulos A, Gupta Y, Zayed H, KatsanosK. Paclitaxel-coated balloons and aneurysm formation in peripheral vessels. J VascSurg. 2015 Nov;62(5):1320-2.
11. Schmidt A et al. First experience with drug-eluting balloons in infrapoplitealarteries: restenosis rate and clinical outcome. J Am Coll Cardiol. 2011 Sep 6;58(11):1105-9.
12. LiistroF et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21.
13. Zeller T, et al. IN.PACT DEEP Trial Investigators. Drug-eluting balloon versus standard balloon angioplasty for infrapoplitealarterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76.
14. 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.
15. 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.
16. Stellarex: Data on file. Spectranetics Document. 2014. Spectranetics Pre-clinical Animal Study ADO097.
17. Gray B, Safety And Efficacy Of The Stellarex DCB With Low Dose Paclitaxel - 4 Year Results from the ILLUMENATE EU RCT, Viva Late Breaking Clinical Trials, 25 June 2020.
*Complex patients refers to high rates of severe calcium, diabetes and renal insufficiency. Primary patency based on Kaplan-Meier estimates.
†† No statistically significant difference in mortality
‡Data from independent CEC (clinical events committee) adjudication of all events resulting in death across all studies Product availability is subject to country regulatory clearance. Please contact your local sales representative to check the availability in your country. Always read the label and follow the directions for use. Philips medical devices should only be used by physicians and teams trained in interventional techniques, including training in the use of this device. Philips reserves the right to change product specifications without prior notification.