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CLINICAL OUTCOMES Protégé™ GPS™ Self-expanding Peripheral and Biliary Stent

DURABILITY ILIAC1 was conducted to confirm the safety and effectiveness of primary stenting using the EverFlex™ and Protégé™ GPS™ self-expanding stent systems for the treatment of lesions in the common and external iliac arteries. 

  • 75 subjects enrolled
  • ≥ 50% stenosis, restenosis or occlusion
  • Target lesion length ≤ 10 cm
  • Target vessel diameter ≥ 4.5 mm and ≤ 11.0 mm

Results of DURABILITY ILIAC study with Protégé™ GPS™ stent:

  • 45/75 patients received a Protégé™ GPS™ stent
  • Nine-month MAE rate of 2.2%
    • 2.2% clinically drive TLR
    • 0% periprocedural death
    • 0% in-hospital MI
    • 0% amputation of treated limb
  • Nine-month primary patency rate of 97.7%
1

Faries, P. Nine-Month Outcomes of DURABILITY ILIAC Trial. VIVA. 2014.