FRONTRUNNER® XP CTO Catheter

Indications

The FRONTRUNNER® XP CTO Catheter is intended to facilitate the intraluminal placement of conventional guide wires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

Contraindications
This device is not intended for use in the cerebral vasculature.

Warnings

• Single use only. Do not resterilize, autoclave, or reuse.
• 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 resterilization, 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 use this device to cross a lesion within a stent.
• Do not use if package is opened or damaged.
• Do not use after the last day of the month of the “Use By” date on the package.
• Do not use this device in the coronary vasculature.

Precautions

• This catheter should only be used by physicians trained in percutaneous interventional techniques in a fully equipped catheterization laboratory or vascular surgery suite.
• Do not use without completely reading and understanding this document.
• Store in a cool, dark, dry place.
• Do not expose the catheter to organic solvents (e.g., alcohol).
• Excessive bending or kinking of the catheter may affect performance.
• Torquing the catheter excessively may cause damage to the product. Withdraw the catheter should it become kinked.
• If strong resistance is felt during manipulation, determine the cause of the resistance before proceeding further. If the cause cannot be determined, withdraw the catheter.

Potential Complications
This product is designed for use by physicians trained in and familiar with percutaneous interventional techniques. Possible complications may include, but are not limited to, the following:

• Vessel dissection, perforation, or injury
• Vascular thrombosis
• Vessel spasm
• Embolism
• Pseudoaneurysm
• Infection and/or sepsis

Please refer to the Instructions For Use for complete information.