Peripheral

Stellarex

Drug-coated 0.035" angioplasty balloon

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Stellarex drug-coated balloon (DCB), featuring EnduraCoat technology, provides top-tier patency to treat common-to-complex lesions with a low drug dose. Low clinically driven target lesion revascularization rates demonstrate the safety of Stellarex across all patients.

Specifications

Product Catalog Number AB35SX040040080
Product Catalog Number AB35SX040040080
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 40 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040060080
Product Catalog Number AB35SX040060080
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 60 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040080080
Product Catalog Number AB35SX040080080
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 80 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040100080
Product Catalog Number AB35SX040100080
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 100 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040120080
Product Catalog Number AB35SX040120080
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 120 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX050040080
Product Catalog Number AB35SX050040080
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 40 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050060080
Product Catalog Number AB35SX050060080
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 60 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050080080
Product Catalog Number AB35SX050080080
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 80 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050100080
Product Catalog Number AB35SX050100080
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 100 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050120080
Product Catalog Number AB35SX050120080
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 120 mm
Shaft length
  • 80 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 16 atm
Product Catalog Number AB35SX060040080
Product Catalog Number AB35SX060040080
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 40 mm
Shaft length
  • 80 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060060080
Product Catalog Number AB35SX060060080
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 60 mm
Shaft length
  • 80 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060080080
Product Catalog Number AB35SX060080080
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 80 mm
Shaft length
  • 80 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060100080
Product Catalog Number AB35SX060100080
Sheath Size
  • 6F
Balloon Diameter
  • 6 mm
Balloon Length
  • 100 mm
Shaft Length
  • 80 mm
Nominal Pressure
  • 8 atm
Rated Burst Pressure
  • 14 atm
Product Catalog Number AB35SX060120080
Product Catalog Number AB35SX060120080
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 120 mm
Shaft length
  • 80 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 12 atm
Product Catalog Number AB35SX040040135
Product Catalog Number AB35SX040040135
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 40 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040060135
Product Catalog Number AB35SX040060135
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 60 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040080135
Product Catalog Number AB35SX040080135
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 80 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040100135
Product Catalog Number AB35SX040100135
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 100 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX040120135
Product Catalog Number AB35SX040120135
Sheath size
  • 6F
Balloon diameter
  • 4 mm
Balloon length
  • 120 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 20 atm
Product Catalog Number AB35SX050040135
Product Catalog Number AB35SX050040135
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 40 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050060135
Product Catalog Number AB35SX050060135
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 60 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050080135
Product Catalog Number AB35SX050080135
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 80 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050100135
Product Catalog Number AB35SX050100135
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 100 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 18 atm
Product Catalog Number AB35SX050120135
Product Catalog Number AB35SX050120135
Sheath size
  • 6F
Balloon diameter
  • 5 mm
Balloon length
  • 120 mm
Shaft length
  • 135 mm
Nominal pressure
  • 10 atm
Rated burst pressure
  • 16 atm
Product Catalog Number AB35SX060040135
Product Catalog Number AB35SX060040135
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 40 mm
Shaft length
  • 135 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060040135
Product Catalog Number AB35SX060040135
Balloon diameter
  • 6 mm
Product Catalog Number AB35SX060060135
Product Catalog Number AB35SX060060135
Sheath size
  • 6F
Balloon length
  • 60 mm
Shaft length
  • 135 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060080135
Product Catalog Number AB35SX060080135
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 80 mm
Shaft length
  • 135 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060100135
Product Catalog Number AB35SX060100135
Sheath size
  • 6F
Balloon diameter
  • 6 mm
Balloon length
  • 100 mm
Shaft length
  • 135 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 14 atm
Product Catalog Number AB35SX060120135
Product Catalog Number AB35SX060120135
Sheath size
  • 6F
Balloon length
  • 120 mm
Balloon diameter
  • 6 mm
Shaft length
  • 135 mm
Nominal pressure
  • 8 atm
Rated burst pressure
  • 12 atm
  • 1. Mathews S. NCVH, 2018. ILLUMENATE Pivotal Stellarex DCB IDE Study 2-Year Outcomes. May 30, 2018. New Orleans, LA.
  • 2. Brodmann M. ILLUMENATE EU RCT: 2-year Results; Oral Presentation. VIVA 2017, Las Vegas, NV. September 11-14, 2017.
  • 3. 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.
  • 4. Holden. Comparing Trials Data in the Management of Calcified Arteries. Charing Cross 2018. April 24-26, 2018; London, UK.
  • 5. Zeller. ILLUMENATE Global: 12-month results with the Stellarex DCB in femoropopliteal lesions. LINC. 2017. Leipzig, Germany.
  • 6. Bard Lutonix Instructions for Use, BAW1387400r3.
  • 7. Zeller. ILLUMENATE Global: 2-year results with the Stellarex DCB in femoropopliteal lesions. LINC. 2018. Leipzig, Germany.
  • 8. Stellarex IFU. P011966-D.
  • 9. Lyden S. Oral presentation, TCT 2016, Washington DC. Nov 2, 2016.
  • 10. Data on file. D044595-00.
  • 11. Schroeder H. et al. Circulation 2017;135:2227-2236
  • 12. H. Schroeder et al. Catheter Cardiovasc Interv. 2015.
  • 13. Mark J, et al. Physical properties of polymers. Cambridge University Press. 3rd ed. 2004.
  • *VasCore (Boston, MA); PSVR: 2.5, KM estimates at day 365 (360 for IN.PACT SFA) Studies shown 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.