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Stellarex Drug-coated 0.035" angioplasty balloon

Stellarex

Drug-coated 0.035" angioplasty balloon

IGTDSTX35DCB

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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.

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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
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.
  • 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.

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