NC Euphora

Indications, Safety, and Warnings

NC Euphora Noncompliant Balloon Dilatation Catheter

Indications

• The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft
• The balloon dilatation catheter is also indicated for postdeployment expansion of balloon expandable stents.

Note: Bench testing was conducted with the NC Euphora™ Rapid Exchange Balloon Dilatation Catheter and commercially available Medtronic balloon expandable stents. Use caution when using this device with different manufacturers’ stents due to difference in stent design.

Contraindications

The catheter is contraindicated for use in:

• Unprotected left main coronary artery
• Coronary artery spasm in the absence of significant stenosis

Please reference appropriate product Instructions for Use for a more detailed list of indications, warnings, precautions and potential adverse events.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

For further information, please contact Medtronic at (888) 283-7868 or consult Medtronic’s website www.Medtronic.com.