What type of stent is a Supera stent?
The Supera peripheral stent is a woven self-expanding stent constructed from nitinol. Six pairs of closed-ended interwoven nitinol wires are arranged in a helical pattern designed to be both flexible and resistant to fracture.
What is Supera stent made of?
SUPERA™ STENT Engineered by a unique interwoven wire technology, this nitinol stent offers physicians unmatched clinical outcomes5-16 across varied lesion complexities and lengths.
What is Supera?
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 7.5 mm, and lesion lengths up …
What is peripheral stent?
Peripheral stents are small tubular metal scaffolds that can be inserted in the peripheral vessels to treat narrowing or blockage within arteries or veins, resulting in improved blood flow. Stents are often composed of a nitinol base and may be plain, drug-coated, or covered with a prosthetic material.
Where are Nitinol stents used?
The first cardiovascular use of Nitinol was in a blood filter to trap clots,60 and the first self-expanding Nitinol stent was developed and used in the aorta23 and the FPAs31 of dogs in 1983.
What is Nitinol used for?
Nitinol is used to manufacture catheter tubes, guidewires, stone retrieval baskets, filters, needles, dental files and archwires and other surgical instruments (6). A particularly important use of Nitinol is in stents.
How long do peripheral artery stents last?
They are made to be permanent — once a stent is placed, it’s there to stay. In cases when a stented coronary artery does re-narrow, it usually happens within 1 to 6 months after placement.
How do Nitinol stents work?
Nitinol stents are manufactured to a size slightly larger than the target vessel size and delivered constrained in a delivery system. After deployment, they position themselves against the vessel wall with a low, “chronic” outward force. They resist outside forces with a significantly higher radial resistive force.
What is Nitinol stent?
Why are stents made of Nitinol?
Most PAD stents therefore are made of self-expandable shape memory Nitinol that allows the device to expand to a pre-set shape once released from the catheter without the assistance of a balloon, and, most importantly, return to this shape after being deformed during limb flexion.
How much does Nitinol cost?
The price is steep, however: a pair costs more than $200. Indeed, the relatively high cost of nitinol has led some manufacturers to use cheaper, copper-based alloys. Nickel-titanium alloys cost about $11 a pound; copper-zinc-aluminium alloys cost about $1 a pound.
How does Nitinol stent work?
Is the Supera peripheral stent system safe and effective?
In conclusion, the SUPERB study results support the safety and effectiveness of theSupera Peripheral Stent System for the treatment of de novo or restenotic lesions or occlusions (≤ 140mm) in the SFA or PPA in subjects with symptomatic peripheral artery disease (PAD). 9.0 DIRECTIONS FOR USE 9.1 Vessel Lesion Evaluation 1.
How do you deploy a Supera stent?
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. PPL00038 (03/21/14) Page 4 of 31 Figure 2: Supera Stent (8) Stent Diameter Reference Vessel Diameter 4.5mm 4.0-4.5mm 5.5mm 4.6-5.5mm 6.5mm 5.6-6.5mm
Is the Supera™ stent MR conditional?
Nonclinical testing has demonstrated that the Supera™ Stent, in single and in overlapped configurations up to 250 mm in length, is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:
Why is the size of the Supera stent oversized?
Due to the mechanical behavior of the woven Supera stent, the stent should not be oversized by more than 1 mm relative to the RVD. This ensures optimum deployment of the Supera stent, maximizing radial strength and assisting in accurate stent length deployment.