RX Herculink Elite STENT

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

• Patients with a contraindication for antiplatelet/ anticoagulant therapy.
• Patients who have a lesion that cannot be crossed with a wire or a balloon angioplasty catheter.
• Patients with bleeding disorders.
• Patients with a known hypersensitivity to cobalt or chrome.
• Target lesions that are resistant to complete balloon inflation.
• Stenting of an arterial vessel where leakage from the artery could be exacerbated by placement of a stent.
• Patients with a target lesion with a large amount of adjacent acute or subacute thrombus.
• For single use only. Do not resterilize or reuse. Note product “Use By” date.
• Do not remove stent from its delivery balloon as removal may damage the stent and/or lead to stent embolization.
• Carefully inspect the RX Herculink Elite Renal Stent System prior to use to verify that the stent has not been damaged in shipment and that the device dimensions are suitable for the specific procedure. Take care to avoid unnecessary handling.
• Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the RX Herculink Elite Renal Stent System, for their intended uses, contraindications, and potential complications.
• Special care must be taken not to handle or in any way disrupt the stent on the balloon. This is most important during stent system removal from the packaging, placement over a guide wire and advancement through a guiding catheter or introducer sheath.
• Do not “roll” the mounted stent with your fingers as this action may loosen the stent from the delivery balloon.
• Use only the appropriate balloon inflation media. Do not use air or any gaseous medium to inflate the balloon as this may cause uneven expansion and difficulty in deployment of the stent.