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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 Everflex Straight
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.

3 Wave

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%.

One and Done

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.