EverFlex™ Peripheral Self-expanding Stent System
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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Overview
Product Details
Physician- Inspired Design
You asked for simple deployment with reduced variability — and the Entrust system delivered.
EverFlex™ Self-expanding Peripheral Stent
- Spiral cell connection pattern enhances flexibility.
- Three-wave peak design produces expansion force that resists compression and provides excellent wall apposition.
- Peak-to-peak connection nodes help to disperse force uniformly among four struts.
- Tantalum markers enhance visibility for easier, more precise positioning.
- Flexible design improves fracture resistance and restores vessel patency.
Bench test data on file at Medtronic.
Entrust™ Delivery System
Ergonomic Handle
- Removable locking pin prevents deployment before use.
- Rotating thumbwheel provides auditory and tactile feedback during stent flowering.
- Comfortable grip designed to aid control during deployment.
Low-profile Catheter
- Tip design eliminates catching of the stent when removing delivery system.
- 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
- Long catheter (150 cm) option allows for extended reach from multiple access sites.
- 0.035” guidewire compatibility provides greater support for SFA procedures.
Triaxial Shaft
Retractable Outer Sheath
Outer sheath retracts inside the isolation sheath during deployment, uncovering the stent and allowing it to expand.
Inner Shaft
Inner shaft assembly provides a lumen for the guidewire and anchors the stent in place.
Isolation Shaft
Isolation sheath provides accuracy and control of stent delivery.
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 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
Study Results
|
Primary Patency (PSVR < 2.0)* |
12-month Data 77.9% |
24-month Data 66.1% |
36-month Data 60.0% |
|
Patency in Lesions ≤ 80 mm |
12-month Data 87.5% |
24-month Data 80.9% |
36-month Data 71.0% |
|
Patency in Lesions ≥ 80 mm |
12-month Data 69.6% |
24-month Data 53.3% |
36-month Data 50.5% |
|
Fracture Rate |
12-month Data 0.4% |
24-month Data 0.9% |
36-month Data 0.9% |
Study Results
|
Successful stent deployment |
Deployment Data 100% |
|
Ability to deliver the stent catheter to the desired location |
Deployment Data 100% |
|
Implanted stent provides coverage of the lesion as intended |
Deployment Data 100% |
|
Stent is deployed accurately |
Deployment Data 100% |
|
Absence of stent elongation |
Deployment Data 95.6% |
Model Specifications
Additional Resources
Contact Us
CardioVascular LifeLine Customer Support 24/7
+1 763-514-4000 (Worldwide)rs.cstechsupport@medtronic.com
*
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.
