Per the Instructions for Use, physicians should prepare the vessel using standard angioplasty technique; balloon size should be greater than or equal to the stent diameter. Refer to the IFU for additional information.
|Labeled Stent Diameter||Reference Vessel Diameter||Nominal Stent Length (mm)||Catheter Outer Sheath Diameter|
|4.5 mm||4.0 - 4.5 mm||20, 30, 40, 60, 80, 100, 120, 150||6F|
|5.0 mm*||4.5 - 5.0 mm||20**, 30**, 40, 60, 80, 100, 120|
|5.5 mm||5.0 - 5.5 mm||20, 30, 40, 60, 80, 100, 120, 150, 180, 200|
|6.0 mm*||5.5 - 6.0 mm||20**, 30**, 40, 60, 80, 100, 120, 150|
|6.5 mm||6.0 - 6.5 mm||20, 30, 40, 60, 80, 100, 120, 150, 180, 200|
|7.0 mm*||6.5 - 7.0 mm||20**, 30**, 40, 60, 80, 100|
|7.5 mm||7.0 - 7.5 mm||20, 30, 40, 60, 80, 100|
The illustration below shows that every 0.5 mm increase provides an estimated 19% to 27% growth in luminal gain (cross-sectional area).
The image below is a percutaneous transluminal angioplasty (PTA) balloon inflation example for a 5.5 mm Supera™ Stent.
Precaution: The vessel/duct after pre-dilatation should be at least the size of the stent diameter. If recommended, vessel/duct diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.
Refer to Instructions For Use (IFU) for additional information.
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 to 140 mm.
The Supera™ Peripheral Stent System is contraindicated in:
Precautions: The Supera™ Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.
Magnetic Resonance Imaging (MRI) Safety Information
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:
Under the scan conditions defined above, the Supera stent is expected to produce a maximum temperature rise of 7.6 C after 15 minutes of continuous scanning.
In nonclinical testing, the image artifact caused by the device extends approximately 2 cm from the Supera stent when imaged with a gradient echo or spin echo sequence and a 3T MRI system.
Potential Adverse Events: Potential adverse events include, but are not limited to: