ELITECROSS

Support Catheter Providing a unique combination of support and shape options to enable a tailored approach to tough lesions.

• UNPARALLELED SUPPORT

• UNPARALLELED PUSHABILITY

• ENHANCED STEERABILITY

• EXTRA LARGE INNER LUMEN can accomodate 0.014” support catheter systems

• Tapered tip and lubricious hydrophilic coating enhance deliverability

Portfolio:

• 0.035” guidewire compatibility

• 82 CM and 132 CM lengths

• XS Straight and XS Angled versions

• DX and IX device compatible

The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

Contraindications

The ELITECROSS™ Support Catheter is not intended for use in the cerebral or coronary vasculature.

Warnings

• Sterile. Sterilized with ethylene oxide gas. Nonpyrogenic. For Single use. Do not resterilize.
• This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use. Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.
• Do not manipulate catheter through a metal sheath as it may result in damage and/or separation of the hydrophilic coating requiring retrieval.
• Do not advance or torque the catheter in the vascular system or into a stenotic lesion (chronic total occlusion) unless the distal end is supported by an ancillary device.
• Do not use with Ethiodol® or Lipiodol® contrast media, or other such contrast media which incorporates the components of these agents.
• Do not expose to organic solvents (e.g., alcohol).
• Do not exceed maximum pressure rating printed on product label.
• If damage is detected in the catheter at any time, replace with an undamaged catheter.

Precautions

• Store in a cool, dark, dry place.
• Do not use if package is opened or damaged.
• Use prior to the “Use By” date.
• Exposure to temperatures above 60°C (140°F) may damage the catheter.
• The catheter should only be used by physicians trained in percutaneous interventional techniques in a fully equipped catheterization laboratory.
• Do not use without completely reading and understanding this document.
• To prevent damage to the catheter during removal from the package, grasp the hub and withdraw the catheter.
• Inspect the catheter before use to verify that its size, shape and condition are suitable for the specific procedure.
• If strong resistance is met during manipulation, determine the cause of resistance before proceeding.
• Torquing the catheter excessively may cause damage to the product and/or, specifically, result in possible separation along the catheter shaft.
• Withdraw the catheter if it becomes kinked, or if binding occurs between the catheter and ancillary device.
• Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.
• Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.
• Advancement, manipulation and withdrawal of the catheter should always be performed under fluoroscopic guidance.