Healthcare Professionals

EverFlex Self-expanding Peripheral Stent with Entrust Delivery System 

Vascular Stenting

Overview

Deliver the same, trusted 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, and common or external iliac arteries. The system's low profile (5 F), triaxial design reduces friction during deployment, which allows for increased accuracy and more predictable stent placement.


U.S. Indications

The EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 mm - 7.5 mm.


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 (150 cm) length allows for an extended reach.
  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.

Entrust Delivery System Demonstration

Watch an animated demonstration of the features of the Entrust delivery system.
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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

 


pdf Deployment Guide for EverFlex with Entrust Delivery System (.pdf)

Step-by-step instructions for preparing and deploying the device.

442KB

pdf Economic Value of the Entrust Delivery System (.pdf)

The Entrust delivery system is designed to provide improved patient outcomes and procedural efficiency.

585KB


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: (877) 526-7890.


Model Specifications

Catheter Length Stent Size Compatibility
80 cm
Reference Number
120 cm
Reference Number
150 cm
Reference Number
Diameter
(mm)
Length 
(mm)
Recommended
Introducer
Sheath
(F)
Guidewire
(in)
Recommended
Lumen Size (mm)
EVD35-06-020-080 EVD35-06-020-120 EVD35-06-020-150 6 20 5 0.035 4.5-5.5
EVD35-06-040-080 EVD35-06-040-120 EVD35-06-040-150 6 40 5 0.035 4.5-5.5
EVD35-06-060-080 EVD35-06-060-120 EVD35-06-060-150 6 60 5 0.035 4.5-5.5
EVD35-06-080-080 EVD35-06-080-120 EVD35-06-080-150 6 80 5 0.035 4.5-5.5
EVD35-06-100-080 EVD35-06-100-120 EVD35-06-100-150 6 100 5 0.035 4.5-5.5
EVD35-06-120-080 EVD35-06-120-120 EVD35-06-120-150 6 120 5 0.035 4.5-5.5
EVD35-06-150-080 EVD35-06-150-120 EVD35-06-150-150 6 150 5 0.035 4.5-5.5
EVD35-07-020-080 EVD35-07-020-120 EVD35-07-020-150 7 20 5 0.035 5.5-6.5
EVD35-07-040-080 EVD35-07-040-120 EVD35-07-040-150 7 40 5 0.035 5.5-6.5
EVD35-07-060-080 EVD35-07-060-120 EVD35-07-060-150 7 60 5 0.035 5.5-6.5
EVD35-07-080-080 EVD35-07-080-120 EVD35-07-080-150 7 80 5 0.035 5.5-6.5
EVD35-07-100-080 EVD35-07-100-120 EVD35-07-100-150 7 100 5 0.035 5.5-6.5
EVD35-07-120-080 EVD35-07-120-120 EVD35-07-120-150 7 120 5 0.035 5.5-6.5
EVD35-07-150-080 EVD35-07-150-120 EVD35-07-150-150 7 150 5 0.035 5.5-6.5

 

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.