Paladin® IEP System

Indications, Safety, & Warnings

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

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Indications for Use

The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin Carotid PTA Balloon System with Integrated Embolic Protection (IEP) should always be used in conjunction with an available embolic protection device when used for post-dilation of self-expanding stents.

Contraindications

    • Contraindicated for use in coronary arteries.
    • Contraindicated for use in patients who cannot tolerate anticoagulant or anti-platelet therapy.
    • Contraindicated for use in patients with known hypersensitivity to nitinol.
    • Contraindicated for use in patients with unresolved bleeding disorders.

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 appropriate antiplatelet and anticoagulation therapy should be administered pre- and post-procedure at a dosage deemed appropriate by the physician.
    • The device is intended for single use only. Do not re-sterilize or reuse, as this can result in compromised device performance.
    • Use before the “Use By” date on the packaging.
    • The integrated filter should not be deployed within a carotid stent.
    • Do not use the Paladin System without prior placement of a distal protection device.
    • The device should not be used in carotid arteries where there is excessive tortuosity proximal to target lesion or where there is a >50° angulation of the stent in common carotid artery/internal carotid artery (ICA).
    • 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 inflated balloon size should approximate the diameter of the vessel just distal to the stenosis. Refer to the balloon compliance chart (see product labeling).
    • Only use a Tuohy-Borst Adaptor that can be opened by rotating the proximal luer. Do not use the Paladin with Tuohy-Borst Adaptors that are activated by pushing or pulling on a proximal hemostatic valve.
    • Avoid over-tightening the hemostasis valve as this may affect balloon inflation/deflation times as well as movement of the guidewire.
    • The Paladin System should be manipulated in the arteries only while using high-quality fluoroscopy.
    • The Paladin System should be advanced with caution if the distal and proximal edge of the carotid stent is not well apposed to the vessel wall, and should be withdrawn with caution if the distal edge of the carotid stent is not well apposed to the vessel wall.
    • The filter should not be expanded to more than 7 mm diameter. Expanding the filter frame to more than 7 mm can cause damage to the filter frame. 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, do not force the knob on the handle to turn further.
    • Balloon inflation pressure should not exceed the labeled rated burst pressure (RPB) of 11 atmospheres (5.5 diameter balloons) or 14 atmospheres (5.0 diameter balloons). Exceeding the rated burst pressure (RBP) may result in balloon rupture, which can result in arterial trauma.
    • Do not advance or retract the Paladin System unless the balloon is fully deflated under vacuum and the filter is fully collapsed. The device should always be used over a guidewire. 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.

Precautions

    • Do not use the Paladin System if the sterile package is compromised or if the device is damaged. Do not use or attempt to straighten a proximal shaft that is kinked. Prepare a new catheter.
    • Before angioplasty, 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.
    • Before insertion of the dilation catheter, administer the appropriate anticoagulant therapy approved in your institution for this procedure.
    • It is recommended to thoroughly wipe the guidewire clean with heparinized saline for better balloon catheter movement on the wire during the loading or exchanging of the balloon catheter.

Adverse Effects

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

    • Abrupt stent closure
    • Angina
    • Arrhythmias
    • Arteriovenous fistula
    • Cardiac tamponade
    • Cardiogenic shock
    • Death
    • Drug reactions, allergic reactions to the contract medium
    • Embolism
    • Heart Failure
    • Hematoma
    • Hemorrhage
    • Hypotension/hypertension
    • Infection
    • Ischemia
    • Pain and tenderness
    • Pericardial effusion
    • Pulmonary edema
    • Femoral pseudoaneurysm
    • Renal failure
    • Respiratory failure
    • Restenosis of the stented segment
    • Stent embolization
    • Stent thrombosis/occlusion
    • Stroke
    • Total occlusion of carotid artery
    • Vessel trauma requiring surgical repair or re-intervention
    • Vessel dissection, perforation, spasm