Herculink Elite™ Rapid Exchange Renal Stent System

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:

• 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.

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

• 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.

Stent Placement ‑ Precautions

• Do not prepare or pre-inflate balloon prior to stent deployment other than as directed. Use balloon purging technique described in the Clinician Use Information section.
• The inflated balloon diameter of the system used to deploy the stent should approximate the diameter of the vessel. Oversizing of the stent can result in a ruptured vessel. To ensure full expansion of the stent, the balloon should be inflated to a minimum of nominal pressure.
• Implanting a stent may lead to dissection of the vessel distal and / or proximal to the stent and may cause acute closure of the vessel requiring additional intervention (surgical intervention, further dilatation, placement of additional stents, or other).
• Do not expand the stent if it is not properly positioned in the vessel. (See Stent / System Removal - Precautions.)
• Stenting across a major bifurcation may hinder or prevent future side branch access.
• Balloon pressures should be monitored during inflation. Do not exceed Rated Burst Pressure (RBP) as indicated on product label. Use of pressures higher than specified on product label may result in a ruptured balloon with possible vessel damage or perforation.
• Stent retrieval methods (use of additional wires, snares and/or forceps) may result in additional trauma to the vasculature and/or the vascular access site. Complications may include bleeding, hematoma or pseudoaneurysm.
• The RX Herculink Elite™ Renal Stent System is intended for deployment and post-deployment dilatation of the stent only and should not be used to dilate other lesions.
• Do not attempt to pull an unexpanded stent back through the introducer sheath / guiding catheter; dislodgment of the stent from the balloon may occur.

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:

• DO NOT retract the Delivery System into the introducer sheath / guiding catheter.
• Position the proximal balloon marker just distal to the tip of the introducer sheath / guiding catheter.
• Advance the guide wire in the anatomy as far distally as safely possible.
• Secure the Delivery System to the introducer sheath / guiding catheter; then remove the introducer sheath / guiding catheter, guide wire and 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:

• Static magnetic field of 1.5 or 3 Tesla
• Spatial gradient field of 2500 Gauss/cm or less
• Maximum whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode) for any duration of MRI scan that would otherwise be safe for the patient without implant.

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:

• Abscess
• Allergic reaction to Cobalt Chromium or contrast agents
• Arrhythmias (ventricular fibrillation, ventricular tachycardia, other)
• Arteriovenous fistula
• Bowel infarct
• Death
• Dialysis
• Dissection
• Drug reaction to antiplatelet agents
• Drug reaction, allergic reaction to contrast media
• Emboli (air, tissue, or thrombotic emboli) resulting in tissue ischemia/infarction
• Emergency surgery to correct vascular complications
• Emergent renal artery bypass surgery
• Extremity ischemia/amputation
• Fever
• Gastrointestinal symptoms from anticoagulation/antiplatelet medication
• Hematoma at vascular access site
• Hemorrhage requiring transfusion
• Hypersensitivity reactions
• Hypertension / hypotension
• Infection and pain at vascular access site
• Intimal tear
• Kidney infarct
• Myocardial infarction
• Myocardial ischemia
• Nephrectomy
• Peripheral neuropathy
• Pseudoaneurysm at vascular access site
• Pseudoaneurysm formation
• Renal artery thrombosis, aneurysm, rupture, perforation, occlusion, spasm, or restenosis
• Renal insufficiency or failure
• Stent migration or embolization
• Stent misplacement
• Stroke/cerebral vascular accident
• Tissue necrosis or ulceration