Peripheral and biliary stents

EverFlex™ self-expanding peripheral stent system with Entrust™ delivery system

The EverFlex™ peripheral self-expanding stent system is used to treat peripheral arterial disease in the SFA and proximal popliteal arteries.

Ordering information
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Features

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.
Learn about the design features of the EverFlex™ stent that make it the number one peripheral stent on the market.

Bench test data on file at Medtronic.

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.
Learn how the Entrust™ delivery system is designed for easy and accurate deployment.

Low-profile catheter

  1. Tip design eliminates catching of the stent when removing delivery system. 
  2. Low-profile (5 Fr) 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.
Learn more about the features of the EverFlex™ stent with Entrust™ delivery system.

Triaxial shaft

Retractable outer sheath

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

Learn more about the triaxial shaft design of the EverFlex™ stent with Entrust™ delivery system.
Inner shaft

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

Learn more about the triaxial shaft design of the EverFlex™ stent with Entrust™ delivery system.
Isolation shaft

Isolation sheath provides accuracy and control of stent delivery.

Learn more about the triaxial shaft design of the EverFlex™ stent with Entrust™ delivery system.

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 (open in new window)

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 (open in new window)

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%

Ordering information

Catheter length Stent dimensions Size compatibility
80 cm
 120 cm
 150 cm
 Unconstrained
stent diameter
(mm)		 Unconstrained
stent length
(mm)		 Sheath/guide
compatibility
(Fr)		 Guidewire
acceptance
(in)		 Recommended
vessel 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
EVD35-08-020-080 EVD35-08-020-120 EVD35-08-020-150 8 20 5 0.035 6.5-7.5
EVD35-08-040-080 EVD35-08-040-120 EVD35-08-040-150 8 40 5 0.035 6.5-7.5
EVD35-08-060-080 EVD35-08-060-120 EVD35-08-060-150 8 60 5 0.035 6.5-7.5
EVD35-08-080-080 EVD35-08-080-120 EVD35-08-080-150 8 80 5 0.035 6.5-7.5
EVD35-08-100-080 EVD35-08-100-120 EVD35-08-100-150 8 100 5 0.035 6.5-7.5
EVD35-08-120-080 EVD35-08-120-120 EVD35-08-120-150 8 120 5 0.035 6.5-7.5
EVD35-08-150-080 EVD35-08-150-120 EVD35-08-150-150 8 150 5 0.035 6.5-7.5

Resources

Related links

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

  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. 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. 
  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.