EverFlex™ Self-expanding Peripheral Stent SystemThe EverFlex stent is deliverable through a 6 F catheter. The spiral-cell connection and peak-to-peak connection nodes are designed to disperse force uniformly, while the three-wave peak design resists compression and provides excellent wall apposition. The EverFlex stent also has a flexible stent design that improves fracture resistance and restores vessel patency. In addition, the broad size matrix (20 mm – 200 mm) allows physicians to choose the most appropriate single-stent fit.
DURABILITY II1 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 results continue to offer evidence that even in long, complex lesions, the EverFlex stent is able to sustain patency and durability.
|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%|
DURABILITY Iliac3 was conducted to confirm the safety and effectiveness of primary stenting using the EverFlex™ and Protégé™ GPS™ Self-expanding stent systems for the treatment of lesions in the common and external iliac arteries. Noteworthy points about the study:
- 75 subjects enrolled
- ≥ 50% stenosis, restenosis or occlusion
- Target lesion length ≤ 10 cm
- Target vessel diameter is ≥ 4.5 mm and ≤ 11.0 mm
- 31/75 patients enrolled in the study received an EverFlex stent
- No major adverse events at nine months
- 0% clinically drive TLR
- 0% periprocedural death
- 0% in-hospital MI
- 0% amputation of treated limb
- Nine-month primary patency rate of 93.2%
2 Rocha-Singh KJ, Bosiers M, Schultz G et al. A Single Stent Strategy in Patients with Lifestyle Limiting Claudication: 3-Year Results From the Durability II Trial. Catheter Cardiovasc Interv. 2015.
3 Faries, P. Nine-Month Outcomes of DURABILITY Iliac Trial. VIVA. 2014.