EverFlex™ Self-expanding Peripheral Stent System

The EverFlex stent is deliverable through a 6 F catheter. The spiral-cell connection and peak-to-peak connection nodes are designed to disperse force uniformly, while the three-wave peak design resists compression and provides excellent wall apposition. The EverFlex stent also has a flexible stent design that improves fracture resistance and restores vessel patency. In addition, the broad size matrix (20 mm – 200 mm) allows physicians to choose the most appropriate single-stent fit.

SE-EverFlex-SprialCell

DURABILITY II1 is the first controlled study to focus on treating long, complex lesions and to specifically test the performance of a single long stent in the superficial femoral artery.

The study enrolled 287 patients:
  • The mean stenosed lesion length was 89.1 mm
  • 70.0% of patients had moderate to severe calcification
  • 48.1% of lesions were totally occluded
  • 73.0% of patients received stents > 100 mm
  • 95% of patients received a single stent
Results2

Three years later, the results continue to offer evidence that even in long, complex lesions, the EverFlex stent is able to sustain patency and durability.

  12-month 24-month 36-month
Freedom from loss of primary patency (PSVR < 2.0)* 77.9% 66.1% 60.0%
Patency in lesions ≤ 80 mm 87.5% 80.9% 71.0%
Patency in lesions ≥ 80 mm 69.6% 53.3% 50.5%
Fracture rate 0.4% 0.9% 0.9%
*Kaplan-Meier Analysis

DURABILITY Iliac3 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. Noteworthy points about the study:
 

  • 75 subjects enrolled
  • ≥ 50% stenosis, restenosis or occlusion
  • Target lesion length ≤ 10 cm
  • Target vessel diameter is ≥ 4.5 mm and ≤ 11.0 mm
     
Results of DURABILITY Iliac study with EverFlex Stent
  • 31/75 patients enrolled in the study received an EverFlex stent
  • No major adverse events at nine months
    • 0% clinically drive TLR
    • 0% periprocedural death
    • 0% in-hospital MI
    • 0% amputation of treated limb
  • Nine-month primary patency rate of 93.2%

1 Matsumura et al. DURABILITY II 12-Month Results. JVS. 2013.
2 Rocha-Singh KJ, Bosiers M, Schultz G et al. A Single Stent Strategy in Patients with Lifestyle Limiting Claudication: 3-Year Results From the Durability II Trial. Catheter Cardiovasc Interv. 2015.
3 Faries, P. Nine-Month Outcomes of DURABILITY Iliac Trial. VIVA. 2014.

UC201602819 EN