EverFlex Self-expanding Peripheral Stent with Entrust Delivery System
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.
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.
Design of EverFlex Self-expanding Peripheral Stent with Entrust Delivery System
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:
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.
|Freedom from loss
of primary patency
(PSVR < 2.0)*
|Patency in lesions ≤ 80 mm||87.5%||80.9%||71.0%|
|Patency in lesions ≥ 80 mm||69.6%||53.3%||50.5%|
* Kaplan-Meier Analysis
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.
|Catheter Length||Stent Size||Compatibility|
Lumen Size (mm)
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.
Rodriguez A, Katz SG. The Use of the Starclose Device for Obtaining Femoral Artery Hemostasis. Vasc Endovascular Surg. 2011; 45(7)627-630.
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.
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.