Stellarex Clinical References

  1. Krishnan P, et al. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017;136:1102-1113.
  2. Schroeder H, et al. Circulation. 2017;135:2227-2236.
  3. Jaff M. Drug-coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the IN.PACT Global Full Clinical Cohort. (Updated data from IN.PACT SFA presented on slide 12) Oral Presentation at: VIVA 2016; September 19-22, 2016; Las Vegas, NV.
  4. IN.PACT Summary of Safety and Effectiveness Data (SSED).
  5. Rosenfield K, Jaff MR, White CJ, et al. NEJM. 2015;373:145-153. Lutonix Summary of Safety and Effectiveness Data (SSED).
  6. Zeller T. Oral presentation. 12-month results of the ILLUMENATE global study with Stellarex DCB. LINC 2017. Bad Krozingen. Germany; Jan 24, 2017.
  7. Granada JF. Future directions, clinical applications and local drug delivery technologies. Presented at the Transcatheter Cardiovascular Therapeutics (TCT) 25th Annual Scientific Symposium. Oct. 27-Nov. 1, 2013. San Francisco, CA. Slide 7, 15.
  8. Schroeder H, Meyer DR, Lux B, et al. Two-year results of a low-dose drug-coated balloon for revascularization of the femoropopliteal artery: outcomes from the ILLUMENATE first-in-human study. Catheter Cadiovasc Interv. 2015;86:278-286.
  9. Spectranetics data on file.
  10. Scheller B, Speck U, Abramjuk C, et al. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110(7):810-814.
  11. Superimposed PK curves from different datasets: Melder R, EuroPCR 2012, Yazdani, et al. Catheterization and Cardiovascular Interventions 2014;83:132-140. Data on file at Spectranetics.
  12. 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.
  13. Fanelli F, et al. Calcium Burden Assessment and Impact on Drug-Eluting Balloons in Peripheral Arterial Disease. Cardiovasc Intervent Radiol. 2014 Apr 2. DOI: 10.1007/s00270-014-0904-3
  14. Reference: Brodmann M. Oral Presentation. VIVA; Sept 13, 2017, Las Vegas, NV
  15. Lutonix DCB IFU