INDICATIONS
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.
CONTRAINDICATIONS
The RX Herculink Elite™ Renal Stent System is contraindicated for use in:
WARNINGS
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.
PRECAUTIONS
Stent Delivery System Handling - Precautions
Stent Placement ‑ Precautions
Stent / System Removal - Precautions
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.
Post Implant - Precautions
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 ADVERSE EVENTS
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 v2.0
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