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%.
|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)|
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.