Alert Indications, Safety, and Warnings

EverFlex Peripheral Self-expanding Stent System

The #1 EverFlex™ stent* offers precision, strength, and flexibility to treat peripheral arterial disease in the SFA and proximal popliteal arteries. Delivered by the physician-inspired Entrust™ delivery system, it offers a 5 F low profile, 0.035” guidewire compatibility, triaxial design, and 150 cm catheter lengths. Medtronic also offers a traditional 6 F pin-pull delivery system.

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EverFlex stent curved in a circle
Alert Indications, Safety, and Warnings

Overview

Simple. Predictable. Precise.

When you need to stent, look to the trusted performance of the #1 EverFlex stent — delivered with ease and precision by the Entrust delivery system.

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EverFlex stent with Entrust delivery system on a white background
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Product Details

Physician-

Inspired

Design

You asked for simple deployment with reduced variability — and the Entrust system delivered.

EverFlex Self-expanding Peripheral Stent

  1. Spiral cell connection pattern enhances flexibility.
  2. Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition.
  3. Peak-to-peak connection nodes help to disperse force uniformly among four struts.
  4. Tantalum markers enhance visibility for easier, more precise positioning.
  5. Flexible design improves fracture resistance and restores vessel patency.

Bench test data on file at Medtronic.

Close-up image of the EverFlex stent with callouts

Entrust Delivery System

Ergonomic Handle

  1. Removable locking pin prevents deployment before use.
  2. Rotating thumbwheel provides auditory and tactile feedback during stent flowering. 
  3. Comfortable grip designed to aid control during deployment. 
Close-up image of Entrust delivery system handle showing the easy grip and rotating thumbwheel

Low-profile Catheter

  1. Tip design eliminates catching of the stent when removing delivery system. 
  2. Low-profile (5 F) delivery system can mean smaller puncture site, less time applying pressure,1 quicker ambulatory rates,2 and reduced vascular access site complications.3,4 
  3. Long catheter (150 cm) option allows for extended reach from multiple access sites.
  4. 0.035” guidewire compatibility provides greater support for SFA procedures. 
Close-up image of Entrust delivery system distal dip and catheter with callouts

Triaxial Shaft

Retractable Outer Sheath

Outer sheath retracts inside the isolation sheath during deployment, uncovering the stent and allowing it to expand.

Close-up image of Entrust delivery system retractable outer shaft

Inner Shaft

Inner shaft assembly provides a lumen for the guidewire and anchors the stent in place.

Close-up image of Entrust delivery system inner shaft

Isolation Shaft

Isolation sheath provides accuracy and control of stent delivery.

Close-up image of Entrust delivery system isolation shaft

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Product Performance

Study Details

The EverFlex stent with Entrust delivery system offers the simplicity and performance you’ve come to expect, and the evidence is in the outcomes: sustained patency and durability even in long, complex lesions.5

The Durability II Study5

The study enrolled 287 patients:

  • 89.1 mm mean stenosed lesion length
  • 70.0% moderate to severe calcification
  • 48.1% total occlusions
  • 73.0% stents ≥ 100 mm
  • 95.0% single stent
  • Low PSVR threshold of < 2.0

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.5  

Three years later, the results continue to offer evidence that even in long, complex lesions, the EverFlex stent can sustain patency and durability.6

Bare Metal Stent Trial Results

Study Results

 

12-month Data

24-month Data

36-month Data

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%

The Entrust Study7

Designed to evaluate the technical success and acute safety of EverFlex stent with Entrust delivery system, this study further demonstrates the accurate and controlled delivery you desire.7

  • 87.1 mm average lesion length7
  • 53.8% total occlusions7

View Performance

Study Results

 

Deployment Data

Successful stent deployment

100%

Ability to deliver the stent catheter to the desired location

100%

Implanted stent provides coverage of the lesion as intended

100%

Stent is deployed accurately

100%

Absence of stent elongation

95.6%

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Model Specifications

pdf EverFlex with Entrust System (.pdf)

365KB

View Specifications

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Additional Resources

Contact Us

CardioVascular LifeLine Customer Support

1-763-526-7890
Toll-free 1-877-526-7890
rs.cstechsupport@medtronic.com

Orders

1-763-514-8510
Toll-free 1-800-716-6700
rs.cusvasorders@medtronic.com

24-hour Technical Support

1-763-514-4000 (Worldwide)
Toll-free 1-800-328-2518

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*

U.S. only. DRG market share data for bare metal stents, November 2020.

†

Kaplan-Meier analysis.

References

1

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

2

Rodriguez A, Katz SG. The Use of the Starclose Device for Obtaining Femoral Artery Hemostasis. Vasc Endovascular Surg. October 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.

5

Matsumura JS, Yamanouchi D, Goldstein JA, et al. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. July 2013;58(1):73-83.e1.

6

Rocha-Singh KJ, Bosiers M, Schultz G, et al. Durability II Investigators. A single stent strategy in patients with lifestyle limiting claudication: 3-year results from the Durability II trial. Catheter Cardiovasc Interv. July 2015;86(1):164-170.

7

Wahlgren. Acute Safety and Technical Results of the EverFlex™ Self-Expanding Stent with new Delivery System (ENTRUST). Presented at LINC 2015.