EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System


SE-EF-Entrust-Features

Distinctive Design Features: 

A. Rotating thumb wheel
  • Auditory and tactile feedback enable greater control during stent flowering
B. One-handed ease-of-use
  • Comfortable grip designed for improved control during one-handed deployment
C. 0.035” guidewire compatible
  • Guidewire provides greater support for SFA procedures
D. EverFlex stent
  • DURABILITY II study demonstrates sustained patency and a best in class fracture rate out to 3 years
  • Broad stent matrix minimizes need to place multiple stents
  • Second-generation design for flexibility and durability in the SFA
E. Triaxial design
  • Isolation sheath reduces friction from the system for increased accuracy and more predictable outcomes
F. NEW 150 cm catheter length
  • Long catheter allows access for an extended reach
G. 5 F delivery system
  • Low profile may allows for:
    • Smaller puncture site
    • Less bleeding during procedures1
    • Quicker ambulatory rates2
    • Reduced vascular access complications3,4
H. Redesigned tip
  • Tip attached to outer catheter eliminates risk of tip catching the stent upon removal of delivery system

Proven Performance

The Entrust system delivers the EverFlex self-expanding peripheral stent, which is backed by clinical evidence in the DURABILITY II5 study. DURABILITY II 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
     
Results6

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-month24-month36-month
Freedom from loss of primary patency (PSVR < 2.0)*77.9%66.1%60.0%
Patency in lesions ≤ 80 mm87.5%80.9%71.0%
Patency in lesions ≥ 80 mm69.6%53.3%50.5%
Fracture rate0.4%0.9%0.9%
*Kaplan-Meier Analysis

1Buchler, J et al. A Randomized Trial of 5 versus 7 French Guiding Catheters for Transfemoral Percutaneous Coronary Stent Implantation, Journal of Interventional Cardiology, Vol. 21, No. 1, 2008.
2Rodriguez A and Katz S, The Use of the Starclose Device for Obtaining Femoral Artery Hemostasis, Vascular and Endovascular Surgery, 2011; 45(7)627-630.
3Meis A, et al, Sonographic Follow-up of the Access Site After Arterial Angiography, J Ultrasound Med 1009: 28:1151-1157.
4Zahn R, et al, Do 5-F Catheters reduce the incidence of a pseudoaneurysm?, Internal Angiology, 1995; Vol 15, No.
5Matsumura et al. DURABILITY II 12-MONTH Results. JVS. 2013.
6Rocha-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.
 


UC201602821 EN