Essential Prescribing Information

Indications

Intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

Contraindications

Not intended for use in the cerebral vasculature.

Warnings

• Single use only. Do not resterilize, autoclave or reuse.
• Do not use this device to cross a lesion with a stent
• Do not use this device in the coronary vasculature.

Precautions

• This catheter should only be use by appropriately trained physicians.
• Do not expose the catheter to organic solvents (e.g., alcohol).
• 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.
• 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.

Adverse Events

• Possible adverse events include, but are not limited to, the following:
  • Vessel dissection, perforation, or injury
  • Vascular thrombosis
  • Embolism
  • Pseudoaneurysm
  • Vessel spasm
  • Infection and/or sepsis

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.

Cordis MICRO GUIDE Catheter XP

Essential Prescribing Information

Indications

The Micro Guide Catheter XP is to be used with the FRONTRUNNER^® XP CTO Catheter.  Intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention.

Contraindications

Not intended for use in the cerebral vasculature.

Warnings

• Single use only.  Do not resterilize, autoclave or reuse.
• Do not use the Micro Guide Catheter XP to cross a lesion within a stent.
• Do not torque or advance the Micro Guide Catheter XP into a stenotic lesion (chronic total occlusion) without the appropriate use with the FRONTRUNNER^® XP CTO Catheter.
• Do not use this device in the coronary vasculature.

Precautions

• This catheter should only be use by appropriately trained physicians.
• Do not expose the Micro Guide Catheter XP to organic solvents (e.g., alcohol).
• 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.
• Excessive bending or kinking of the catheter may affect performance.
• Torquing the catheter excessively may cause damage to the product.  Withdraw the catheter if it becomes kinked, or if binding occurs between the Micro Guide Catheter XP.
• Do not advance or torque the Micro Guide Catheter XP unless the distal end is supported by the FRONTRUNNER^® XP Catheter.

Adverse Events

Possible adverse events include, but are not limited to, the following:

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

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.