Braided Stents
Supera Peripheral Stent System
Indications for Use
The Supera Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5mm, and lesion lengths up to 140mm.
Key Specifications
- Closed-end, braided self-expanding stent made of Nitinol (nickel-titanium alloy) wire material, consisting of six interwoven wires
- Premounted on a 6Fr or 7Fr delivery system
- No radiopaque markers on the stent
- Over-the-wire (OTW) delivery system compatible with 0.014” and 0.018” guidewires
- Delivery system lengths: 80cm and 120cm (6Fr), 120cm (7Fr)
- Reciprocating deployment mechanism (Stent Driver) that incrementally moves the stent distally out of the outer sheath via Thumb Slide on Handle
- Stent diameters: 4.5 mm (for reference vessel diameter 4.0-4.5 mm), 5.5 mm (4.6-5.5 mm), 6.5 mm (5.6-6.5 mm)
- Stent lengths: 20 mm, 30 mm, 40 mm, 60 mm, 80 mm, 100 mm, 120 mm, 150 mm
- Catheter outer sheath diameter: 6F (2.00 mm / 0.079 inches), 7F (2.54 mm / 0.100 inches)
- Stent foreshortens by approximately 60% (±5%) upon deployment (e.g., 20 mm labeled stent deploys to 18-22 mm)
- Stent constrained to three times its nominal length within the outer sheath
- Radiopaque markers: Stent Length Marker and Distal Sheath Marker for identifying nominal stent length and lesion coverage
- Catheter tip: Atraumatic, radiopaque, located at distal end of catheter shaft
- Sterilized with ethylene oxide gas; non-pyrogenic; single-use only
- Store at room temperature in a dry, dark, cool place
- MR Conditional under specific conditions (1.5T or 3.0T static field, SAR limits, up to 250 mm length)
Description
The Supera Peripheral Stent System consists of a closed end, braided self-expanding stent made of Nitinol (nickel-titanium alloy) wire material that is premounted on a 6Fr or 7Fr delivery system. The stent does not include radiopaque markers. The over-the-wire (OTW) stent delivery system is compatible with a 0.014” and a 0.018” guide wire and comes in lengths of 80cm and 120cm (6Fr) and 120cm (7Fr). The delivery system includes a reciprocating mechanism (Stent Driver) that incrementally moves the stent distally out of the outer sheath. This motion allows for the distal end of the stent to first come in contact with the targeted vessel, setting the distal reference point, and continues to feed the stent out of the sheath as the target wall is exposed by the proximal movement of the catheter. This stent deployment is achieved by the reciprocation of the Thumb Slide located on the Handle. On the final stroke, the Deployment Lock is toggled and the last deployment stroke is made.