Healthcare Professionals

EverFlex Self-expanding Peripheral Stent with Entrust Delivery System

Peripheral Stenting

Overview

Deliver the same, trusted Protégé EverFlex stent with the ease of single handed deployment when choosing the EverFlex™ self-expanding peripheral stent with Entrust™ delivery system to treat PAD in the SFA, proximal popliteal, subclavian, and common or external iliac arteries. The system's low profile (5Fr), triaxial design reduces friction during deployment, which allows for increased accuracy and more predictable stent placement. The system is available in 150cm shaft lengths for situations where extended reach is needed.


Indications

The EverFlex self-expanding peripheral stent with Entrust delivery system is indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA); or lesions believed to be at high risk for restenosis following PTA in the common iliac, external iliac, superficial femoral, proximal popliteal, or subclavian arteries. Stenting is intended to improve and maintain artery luminal diameter.

All indications related to the EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM are not approved globally, please refer to the complete Instructions for Use manual for the indication for Use approved in your geography.


Product Details

Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System

Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System

  1. Redesigned tip eliminates risk of tip catching the stent upon delivery system removal.
  2. Low profile (5 F) delivery system may allow for smaller puncture site, less time applying pressure,1 quicker ambulatory rates,2 and reduced vascular access complications.3,4
  3. Long catheter (150cm) length option allows for access via femoral or brachial arteries.
  4. Triaxial design with isolation sheath to reduce friction from the system for increased accuracy and more predictable outcomes.
  5. Rotating thumb wheel provides auditory and tactile feedback to enable greater control during stent flowering.
  6. Broad stent matrix minimizes need to place multiple stents.
  7. 0.035" guidewire compatibility provides greater support for SFA procedures.
  8. Comfortable grip designed for improved control during one-handed deployment.

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.

Three years later, the results6 continue to offer evidence that even in long, complex lesions, the EverFlex self-expanding peripheral 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

 


Manuals and Technical Guides

Instructions for Use
Find this technical manual in the product labeling supplied with each device or by calling technical support for cardiovascular services: +1 763-526-7890.


Model Specifications

Catheter Length Stent Size Compatibility
Reference Number
Usable Length
80 cm
Reference Number
Usable Length
120 cm
Reference Number
Usable Length
150 cm
Diameter
(mm)
Length 
(mm)
Recomm.
Introducer
Sheath
(F)
Guidewire
(in)
Recomm.
Lumen Size
(mm)
EVX35-05-020-080 EVX35-05-020-120 EVX35-05-020-150 5 20 5 0.035 3.5-4.5
EVX35-05-040-080 EVX35-05-040-120 EVX35-05-040-150 5 40 5 0.035 3.5-4.5
EVX35-05-060-080 EVX35-05-060-120 EVX35-05-060-150 5 60 5 0.035 3.5-4.5
EVX35-05-080-080 EVX35-05-080-120 EVX35-05-080-150 5 80 5 0.035 3.5-4.5
EVX35-05-100-080 EVX35-05-100-120 EVX35-05-100-150 5 100 5 0.035 3.5-4.5
EVX35-05-120-080 EVX35-05-120-120 EVX35-05-120-150 5 120 5 0.035 3.5-4.5
EVX35-05-150-080 EVX35-05-150-120 EVX35-05-150-150 5 150 5 0.035 3.5-4.5
EVX35-06-020-080 EVX35-06-020-120 EVX35-06-020-150 6 20 5 0.035 4.5-5.5
EVX35-06-040-080 EVX35-06-040-120 EVX35-06-040-150 6 40 5 0.035 4.5-5.5
EVX35-06-060-080 EVX35-06-060-120 EVX35-06-060-150 6 60 5 0.035 4.5-5.5
EVX35-06-080-080 EVX35-06-080-120 EVX35-06-080-150 6 80 5 0.035 4.5-5.5
EVX35-06-100-080 EVX35-06-100-120 EVX35-06-100-150 6 100 5 0.035 4.5-5.5
EVX35-06-120-080 EVX35-06-120-120 EVX35-06-120-150 6 120 5 0.035 4.5-5.5
EVX35-06-150-080 EVX35-06-150-120 EVX35-06-150-150 6 150 5 0.035 4.5-5.5
EVX35-07-020-080 EVX35-07-020-120 EVX35-07-020-150 7 20 5 0.035 5.5-6.5
EVX35-07-040-080 EVX35-07-040-120 EVX35-07-040-150 7 40 5 0.035 5.5-6.5
EVX35-07-060-080 EVX35-07-060-120 EVX35-07-060-150 7 60 5 0.035 5.5-6.5
EVX35-07-080-080 EVX35-07-080-120 EVX35-07-080-150 7 80 5 0.035 5.5-6.5
EVX35-07-100-080 EVX35-07-100-120 EVX35-07-100-150 7 100 5 0.035 5.5-6.5
EVX35-07-120-080 EVX35-07-120-120 EVX35-07-120-150 7 120 5 0.035 5.5-6.5
EVX35-07-150-080 EVX35-07-150-120 EVX35-07-150-150 7 150 5 0.035 5.5-6.5
EVX35-08-020-080 EVX35-08-020-120 EVX35-08-020-150 8 20 5 0.035 6.5-7.5
EVX35-08-040-080 EVX35-08-040-120 EVX35-08-040-150 8 40 5 0.035 6.5-7.5
EVX35-08-060-080 EVX35-08-060-120 EVX35-08-060-150 8 60 5 0.035 6.5-7.5
EVX35-08-080-080 EVX35-08-080-120 EVX35-08-080-150 8 80 5 0.035 6.5-7.5
EVX35-08-100-080 EVX35-08-100-120 EVX35-08-100-150 8 100 5 0.035 6.5-7.5
EVX35-08-120-080 EVX35-08-120-120 EVX35-08-120-150 8 120 5 0.035 6.5-7.5
EVX35-08-150-080 EVX35-08-150-120 EVX35-08-150-150 8 150 5 0.035 6.5-7.5

 See product catalog for complete, detailed product information.


1

Buchler JR, Ribeiro EE, Falcao JL, et al. A Randomized Trial of 5 versus 7 French Guiding Catheters for Transfemoral Percutaneous Coronary Stent Implantation. J Interv Cardiol. 2008; 21(1):50-55.

2

Rodriguez A, Katz SG. The Use of the Starclose Device for Obtaining Femoral Artery Hemostasis. Vasc Endovascular Surg. 2011; 45(7)627-630.

3

Meis A, Osada N, Schlegel PM, et al. Sonographic Follow-up of the Access Site after Arterial Angiogra­phy: Impact on the Detected Complication Rate. J Ultrasound Med. 2009; 28(9):1151-1157.

4

Zahn R, Thoma S, Fromm E, et al. Do 5 F Catheters Reduce the Incidence of a Pseudoaneurysm? Int Angiol. 1995; 15(3):257-260.