Neuroguard IEP^® System

Indications, Safety, & Warnings

The Neuroguard IEP System is approved for sale in the USA. Caution: Federal (United States) law restricts this device to sale by or on order of a physician.

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Indications for Use

The Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in subjects at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below:

• Patients with symptomatic stenosis of the common or internal carotid artery with ≥ 50% as determined by angiography using NASCET methodology, OR Patients with asymptomatic stenosis of the common or internal carotid artery with ≥ 80% as determined by angiography using NASCET methodology.
• Patients with reference vessel diameters 4.0 – 8.0 mm.

This device is also indicated for post-dilation of the stent component with simultaneous capture and removal of embolic material. The Neuroguard IEP System should always be used in conjunction with an available primary distal embolic protection device as described in the IFU.

Contraindications

The Neuroguard IEP^® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is contraindicated for use in:

• Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guidewire, catheter, introducer sheath, delivery system or embolic protection device.
• Patients with uncorrected bleeding disorders.
• Patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.

Warnings

• Only physicians who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects and hazards commonly associated with carotid artery interventional procedures should use this device.
• The Neuroguard IEP System is intended for single use only. Do not re-sterilize or reuse, as this can result in compromised device performance.
• If it is suspected that the sterile barrier seal has been opened or comprised, do not use the Neuroguard IEP System. Please return to the manufacturer.
• The appropriate antiplatelet, anticoagulant and if necessary, vasodilator therapy, must be used during the pre- and post-procedure to minimize the risk of embolism and thrombus.
• Maintain continuous flush while inserting and removing the Neuroguard IEP System over the guidewire. Perform all exchanges slowly to prevent air embolism or trauma to the artery.
• Never withdraw or move an intravascular device against any resistance until the cause is determined. Applying excessive force during delivery or retrieval of the Neuroguard IEP System can potentially result in loss or damage to the device or components or injury (perforation/dissection) to the vessel.
• Multiple stents should not be used in an overlapping configuration.
• A partially deployed stent cannot be repositioned or retracted into the outer sheath. Retraction, or repositioning of a stent by force, could cause deformation of the stent, damage to the blood vessel and/or to the delivery catheter. The stent cannot be removed after implantation.
• Balloon inflation pressure should not exceed the labeled rated burst pressure (RBP). Exceeding the rated burst pressure (RBP) may result in balloon rupture, which can traumatize the artery.
• The stent may cause thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• This device contains nitinol, an alloy of nickel and titanium. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials.
• The Neuroguard IEP System should always be used with a primary distal embolic filter. The device was studied with the FilterWire™ EZ, Emboshield^® NAV6, and SpiderFX™ filters. The safety and effectiveness has not been evaluated with other embolic protection systems.

Precautions

General Precautions

• The Neuroguard IEP System should be manipulated in the arteries only under high-quality fluoroscopy.
• Carefully inspect the Neuroguard IEP System to verify that the device has not been damaged in shipment. Do not use if the device is damaged. The delivery system has an internal hypotube. Take care to avoid unnecessary handling, which may kink or damage the delivery system. Do not use or attempt to straighten a proximal shaft that is kinked. Prepare a new catheter.
• Before the procedure, the catheter should be examined to verify functionality and ensure that its labeled size and shape are suitable for the procedure for which it is to be used.
• Do not use the product after the Use by Date specified on the label.
• Special care must be taken not to disrupt the stent or the filter on the delivery system.
• Avoid over-tightening the hemostasis valve as this may affect balloon inflation / deflation times as well as movement of the guidewire.
• If resistance is met during delivery system introduction, the system should be withdrawn and another system used.
• Only prepare and flush the Neuroguard IEP System with the supplied flushing syringes and flushing tips.
• Venous access should be available during carotid stenting to manage bradycardia and/or hypotension by either pharmaceutical intervention or placement of a temporary pacemaker, if needed.
• Use only recommended balloon inflation solution. Do not use air or other gaseous medium to inflate the balloon. Nonionic contrast medium has different viscosity and precipitation levels than does the ionic type, which may prolong inflation/deflation times.
• The delivery system is not designed for use with power injection. Use of power injection may adversely affect device performance.
• Caution should be used if pre-dilating the lesion without embolic protection as this may increase the risk of an adverse outcome.
• Do not advance or retract the Neuroguard IEP System unless the balloon is fully deflated under vacuum and the filter is fully collapsed. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Filter Precautions

• Over-expanding the filter frame can cause damage to the filter frame and to the vessel. The filter will automatically stop expanding at 7 mm, and the knob on the handle will stop turning beyond this point. If resistance is met, the knob on the handle should not be forced.
• Do not force the knob if it is not turning freely. Take care not to oversize the filter to minimize vessel trauma.

Stent Precautions

• Ensure the stent system is fully flushed with heparinized saline prior to use. See delivery system preparation instructions below.
• Overstretching of the artery may result in rupture and life-threatening bleeding.

Stent Post-Implant Precautions

• Care must be exercised when crossing a newly deployed stent with other interventional devices to avoid disrupting the stent geometry and placement of the stent.
• In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
• After stent implantation, the patient should be followed up by their physician at regular intervals to ensure that the stent performance has not changed over time.
• For patients, if a serious incident related to the device occurs, immediately report the incident to a healthcare professional. For healthcare professionals, immediately report a serious incident to Contego.

MRI COMPATIBILITY

Potential Adverse Effects

Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to the following:

• Angina
• Allergic reactions (including to antiplatelet agents, contrast medium or stent materials)
• Aneurysm
• Arrhythmias
• Arterial occlusion/thrombosis at puncture site
• Bleeding from anticoagulant or antiplatelet medications
• Bradycardia
• Carotid artery spasm
• Cerebral edema
• Cerebral hemorrhage
• Cerebral ischemia/transient ischemia attack (TIA)
• Cardiac tamponade
• Cardiogenic shock
• Death
• Detachment and/or implantation of a component
• Embolism
• Fever
• Filter thrombosis/occlusion
• Groin hematoma, with or without surgical repair
• Heart failure
• Hematoma
• Hemorrhage
• Hypotension/hypertension
• Infection
• Ischemia/infarction of tissue/organ
• Myocardial infarction
• Pain and tenderness
• Pericardial effusion
• Pulmonary edema
• Pseudoaneurysm at the vascular access site
• Renal failure/insufficiency
• Respiratory failure
• Restenosis of the stented segment
• Seizure
• Severe unilateral headache
• Stent embolization
• Stent / filter entanglement / damage
• Stent malapposition
• Stent migration
• Stent misplacement
• Stent thrombosis/occlusion
• Stroke / cerebrovascular accident (CVA)
• Total occlusion of carotid artery
• Vessel dissection, perforation, spasm or recoil
• Vessel trauma requiring surgical repair or re-intervention