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EverFlex™ Self-Expanding Peripheral Stent System
The EverFlex Self-Expanding Peripheral Stent System is now indicated for use in the Superficial Femoral Artery (SFA) and/or proximal popliteal artery. In addition to the new indication, it is now available in a 200 mm length. The broad size matrix (20 mm – 200 mm) allows physicians to choose the most appropriate single-stent fit.
200 mm EverFlex Self-Expanding Peripheral Stent
Strong clinical evidence from the DURABILITY II trial proves the safety and effectiveness of the EverFlex technology. The EverFlex stent, which is deliverable through a 6 F catheter, offers superior durability, strength, and precise placement. 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. EverFlex also has a flexible stent design that improves fracture resistance and restores vessel patency.
DURABILITY II was the first study to focus on long lesions and to specifically test the performance of a single 200 mm stent in the SFA. Other noteworthy points about the study:
- 287 patients with long, complex and highly calcified lesions were enrolled
- 73% of patients received a stent 100 mm or longer
- 46.2% received a stent 150 mm or longer.
The study results:
- No major adverse events at 30 days.
- Proven stent patency rate at one year by Kaplan-Meier:
- Lesion length ≤ 80 mm 86.2%
- Lesion length > 80 mm 69.6%
- Low one-year stent fracture rate of 0.4%.
DURABILITY II Clinical Study
| Catheter Length | Stent Size | Compatibility | ||||
| 80 cm Product Catalog Number | 120 cm Product Catalog Number | Diameter (mm) | Length (mm) | Rec. Introducer Sheath (F) | Guidewire (in) | Rec. Lumen Size (mm) |
|---|---|---|---|---|---|---|
| PRB35-06-020-080 | PRB35-06-020-120 | 6 | 20 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-030-080 | PRB35-06-030-120 | 6 | 30 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-040-080 | PRB35-06-040-120 | 6 | 40 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-060-080 | PRB35-06-060-120 | 6 | 60 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-080-080 | PRB35-06-080-120 | 6 | 80 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-100-080 | PRB35-06-100-120 | 6 | 100 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-120-080 | PRB35-06-120-120 | 6 | 120 | 6 | 0.035 | 4.5-5.5 |
| PRB35-06-150-080 | PRB35-06-150-120 | 6 | 150 | 6 | 0.035 | 4.5-5.5 |
| N/A | PRB35-06-200-120 | 6 | 200 | 6 | 0.035 | 4.5-5.5 |
| PRB35-07-020-080 | PRB35-07-020-120 | 7 | 20 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-030-080 | PRB35-07-030-120 | 7 | 30 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-040-080 | PRB35-07-040-120 | 7 | 40 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-060-080 | PRB35-07-060-120 | 7 | 60 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-080-080 | PRB35-07-080-120 | 7 | 80 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-100-080 | PRB35-07-100-120 | 7 | 100 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-120-080 | PRB35-07-120-120 | 7 | 120 | 6 | 0.035 | 5.5-6.5 |
| PRB35-07-150-080 | PRB35-07-150-120 | 7 | 150 | 6 | 0.035 | 5.5-6.5 |
| N/A | PRB35-07-200-120 | 7 | 200 | 6 | 0.035 | 5.5-6.5 |
| PRB35-08-020-080 | PRB35-08-020-120 | 8 | 20 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-030-080 | PRB35-08-030-120 | 8 | 30 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-040-080 | PRB35-08-040-120 | 8 | 40 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-060-080 | PRB35-08-060-120 | 8 | 60 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-080-080 | PRB35-08-080-120 | 8 | 80 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-100-120 | PRB35-08-100-120 | 8 | 100 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-120-120 | PRB35-08-120-120 | 8 | 120 | 6 | 0.035 | 6.5-7.5 |
| PRB35-08-150-120 | PRB35-08-150-120 | 8 | 150 | 6 | 0.035 | 6.5-7.5 |
| N/A | PRB35-08-200-120 | 8 | 200 | 6 | 0.035 | 6.5-7.5 |
Indication: The EverFlex™ Self-Expanding Peripheral Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 180 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal poplitealarteries with reference vessel diameters ranging from 4.5 – 7.5 mm.
Indication: The EverFlex™ Self-Expanding Peripheral Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or, restenotic lesions up to 180mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 – 7.5 mm.
Contraindications: Use of the EverFlex™ Self-Expanding Peripheral Stent System is contraindicated in patients with known hypersensitivity to nickel titanium; patients contraindicated for anticoagulant and/or antiplatelet therapy; patients who have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system.
Potential Adverse Events: Potential adverse events which may be associated with the use of a stent in the SFA and proximal popliteal arteries include, but are not limited to: Allergic reaction, Amputation, Arterial dissection/perforation, Bleeding disorders (including GI, lymphatic), Infection (local or systemic including bacteremia or septicemia), Pseudoaneurysm, Restenosis, Stent/Vessel Thrombosis, Surgical or endovascular intervention.
See the Instructions for Use provided with the product for a complete list of warnings, precaution, adverse events and device information.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
