Data on file at Abbott unless otherwise noted.
MAT-2114443 v1.0
Indications
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.
Contraindications
The Supera™ Peripheral Stent System is contraindicated in:
Warnings
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:
MAT-2103597 v3.0
The Absolute Pro™ Vascular Self-Expanding Stent System is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm to 9.1 mm and lesion lengths up to 90 mm.
There are no known contraindications.
DO NOT USE IF THE TEMPERATURE INDICATOR IS BLACK.
This device is intended for single-use only; do not reuse. Do not resterilize. Do not use if the package is open or damaged.
Use prior to the “Use By” date specified on the package.
Persons with known hypersensitivities to nitinol and / or its components (e.g. nickel, titanium) may suffer an allergic reaction to this implant.
The safety and effectiveness of multiple overlapping stents have not been established. However, when multiple stents are required, stent materials should be of similar composition.
Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
Use of an undersized guide wire, with insufficient support, may cause kinking in the Stent Delivery System.
Use of appropriate anticoagulant and/or antiplatelet therapy per standard of care is recommended for use with this stent system.
Inspect the product prior to use. Do not use if the package is open or damaged. Avoid unnecessary handling, which may kink or damage the Delivery System.
Only physicians familiar with the complications, side effects and hazards commonly associated with iliac stent placement should use this device.
The stent is not designed for resheathing or recapturing. The stent is not designed for repositioning once the stent has apposed the vessel wall.
Once the stent is apposed to the vessel, it is not recommended to remove the stent with the delivery system.
The Absolute Pro™ is intended to perform as a system. Do not remove the stent for use in conjunction with other dilatation catheters; do not use the Absolute Pro™ in conjunction with other stents.
Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the Absolute Pro™ for their intended uses, contraindications, and potential complications.
Stent retrieval methods (use of additional wires, snares and / or forceps) may result in additional trauma to the vasculature.
Do not attempt to pull a partially-expanded stent back through the introducer sheath or guiding catheter. The stent is not designed for recapturing. The stent is not designed for repositioning once the stent has apposed the vessel. Once the stent is apposed to the vessel, it is not recommended to remove the stent with the Delivery System.
Should unusual resistance be felt at any time during lesion access or removal of the Delivery System post stent implantation, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit. Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment or deployment in an unintended location.
When removing the Delivery System as a single unit:
Failure to follow these steps and / or applying excessive force to the Delivery System can potentially result in loss or damage to the stent and / or Delivery System components.
Magnetic Resonance Imaging (MRI):
Non-clinical testing has demonstrated that the Absolute Pro™ Stent in single and in overlapped configurations up to 190 mm in length is MR Conditional as defined in ASTM F2503. For placement in the iliac artery, patients with this implant may be scanned safely anytime after implantation under the following conditions:
The Absolute Pro™ stent should not migrate in this MRI environment. Magnetic force on the Absolute Pro™ stent was tested according to ASTM F2052-06e. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating.
Stent heating during MRI was derived by using the measured non-clinical, in vitro temperature rise according to ASTM F2182-09 in a GE Signa HDx 3 Tesla scanner and in a GE 1.5 Tesla coil in combination with the calculated local specific absorption rates (SARs) in a digitized human model. For the SAR conditions above, the greatest in-vivo temperature rise was calculated to be 5.3°C at 128 MHz for a stent length of 60 mm. The calculations do not take into consideration the cooling effects of blood flow, and therefore, actual in-vivo rises are expected to be lower.
The effects of MRI on overlapped stents greater than 190 mm in length or stents with fractured struts are unknown. Image artifact may be present when scanning the Absolute Pro™ stent as demonstrated in non-clinical testing performed according to ASTM F2119-07 in a GE Signa HDx 3 Tesla scanner. The image artifact (both inside and outside the device lumen) extends approximately 5 mm from the device using the spin echo sequence and 10 mm from the device using the gradient echo sequence. MR image quality may be compromised if the area of interest is in the exact same area, or relatively close to, the position of the Absolute Pro™ stent. Therefore, it may be necessary to optimize the MR imaging parameters in the presence of Absolute Pro™ stents.
Abbott Vascular recommends that patients register the MR conditions in this IFU with the MedicAlert Foundation or equivalent organization. The Medic-Alert Foundation can be contacted by phone at: (888) 633-4298, (209) 668-3333 or on the internet at www.medicalert.org.
Below is a list of the potential adverse effects (e.g., complications) that may be associated with the use of the device:
MAT-2114529 v2.0
The Omnilink Elite™ Stent System is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5.0 mm and ≤ 11.0 mm, and lesion lengths up to 50 mm.
There are no known contraindications.
The device should be used only by physicians trained in angiography and percutaneous transluminal angioplasty and stent placement.
Should unusual resistance be felt at any time during either lesion access or removal of the delivery system post-stent implantation, the entire system should be removed as a single unit.
When removing the delivery system as a single unit:
Failure to follow these steps and / or applying excessive force to the delivery system can potentially result in loss or damage to the stent and / or delivery system components.
If it is necessary to retain guide wire position for subsequent vessel access, leave the guide wire in place and remove all other system components.
Exercise great care when crossing a newly deployed stent with a guide wire or balloon catheter to avoid disrupting the stent geometry.
Non-clinical testing has demonstrated that the Omnilink Elite™ stent, in single and in overlapped configurations up to 100 mm in length, is MR Conditional as defined in ASTM F2503. It can be scanned safely under the conditions listed in the Instructions for Use.
Potential complications associated with percutaneous iliac artery treatment, including the use of an iliac stent, may include, but are not limited to, the following:
MAT-2114535 v2.0
The RX Herculink Elite™ Renal Stent System is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic atherosclerotic lesion (≤ 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 - 7.0 mm. Suboptimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mmHg peak systolic or ≥ 10 mmHg mean translesional pressure gradient, flow-limiting dissection, or TIMI [Thrombolysis In Myocardial Infarction] flow < 3.
The RX Herculink Elite™ Renal Stent System is contraindicated for use in:
The long term safety and effectiveness of this device for use in the renal arterial system have not been established.
Should unusual resistance be felt at any time during lesion access or Delivery System removal, the introducer sheath/guiding catheter and stent system should be removed as a single unit. Applying excessive force to the Stent Delivery System can potentially result in loss or damage to the Stent and Delivery System components. (See Stent/System Removal – Precautions.)
Since the use of this device carries the associated risk of subacute thrombosis, vascular complications and/or bleeding events, judicious selection of patients is necessary.
Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
Once fully deployed, the stent cannot be repositioned.
Persons allergic to L605 cobalt chromium alloy may suffer an allergic reaction to this implant.
Only physicians familiar with the complications, side effects and hazards commonly associated with renal stent placement should use this device.
The RX Herculink Elite™ Renal Stent System is intended to perform as a system. The stent should not be removed for use in conjunction with other dilatation catheters, nor should the RX Herculink Elite™ Renal Stent System be used in conjunction with other stents.
The safety and effectiveness of multiple overlapping stents have not been established. However, when multiple stents are required, stent materials should be of similar composition.
Should unusual resistance be felt at any time during either lesion access or removal of the Delivery System post-stent implantation, the entire system should be removed as a single unit.
When removing the Delivery System as a single unit:
Failure to follow these steps and / or applying excessive force to the Delivery System can potentially result in loss or damage to the stent and / or delivery system components.
If it is necessary to retain guide wire position for subsequent vessel access, leave the guide wire in place and remove all other system components.
Great care must be exercised when crossing a newly deployed stent with a guide wire or balloon catheter to avoid disrupting the stent geometry.
Magnetic Resonance Imaging (MRI): Non-clinical testing has demonstrated that the Herculink Elite™ stent, in single and in overlapped configurations up to 33 mm in length, is MR Conditional. It can be scanned safely under the following conditions:
MRI at 1.5 or 3 Tesla may be performed immediately following the implantation of the Herculink Elite™ stent.
The Herculink Elite™ stent should not migrate in this MRI environment. Magnetic force on the Herculink Elite™ stent was tested according to ASTM F2052-06e. Non-clinical testing at field strengths greater than 3 Tesla has not been performed to evaluate stent migration or heating.
Stent heating was derived by using the measured non-clinical, in vitro temperature rise according to ASTM F2182-09 in a GE Signa HDx 3 Tesla scanner and in a GE 1.5 Tesla coil in combination with the local specific absorption rates (SARs) in a digitized human heart model. The temperature rise was derived by a validated calculation. At overlapped lengths up to 33 mm, the Herculink Elite™ stent produced a non-clinical maximum local temperature rise of less than 3ºC at a maximum whole body averaged SAR of 2.0 W/kg (normal operating mode) for an MRI sequence of 15 minutes. These calculations do not take into consideration the cooling effects of blood flow.
The effects of MRI on overlapped stents greater than 33 mm in length or stents with fractured struts are unknown.
Image artifact may be present when scanning the Herculink Elite™ stent as demonstrated in non-clinical testing performed according to ASTM F2119-07 in a GE Signa HDx 3 Tesla scanner. The image artifact (both inside and outside the device lumen) extends approximately 7 mm from the device using the spin echo sequence (TR = 500 ms; TE = 20 ms; flip angle = 90°) and 13 mm from the device using the gradient echo sequence (TR = 100 ms; TE = 15 ms; flip angle = 30°). MR image quality may be compromised if the area of interest is in the exact same area, or relatively close to, the position of the Herculink Elite™ stent. Therefore, it may be necessary to optimize the MR imaging parameters in the presence of Herculink Elite™ stents.
Potential complications associated with percutaneous renal artery treatment including the use of a renal stent may include, but are not limited to, the following:
MAT-2114538 v1.0
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