Sprinter^® MX^®2 Semicompliant Multi-Exchange Balloon Dilatation Catheter

Indications for Use

Medtronic PTCA catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

NC Stormer and Sprinter balloon dilatation catheters (balloon models 2.5 mm to 4.0 mm) are also indicated for the post-delivery expansion of balloon-expandable stents. (Note: Bench testing was conducted with the NC Stormer and Sprinter balloon dilatation catheters and marketed balloon-expandable stents. Consideration should be taken when these devices are used with different manufacturers’ stents due to differences in stent design.)

Contraindications

Use in unprotected left main arteries or in patients with coronary artery spasm in the absence of a signiÞcant stenosis thought to be of hemodynamic significance.

Warnings/Precautions

PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery presents special risks and requires careful consideration.

Adverse Effects

These include, but are not limited to, death, myocardial infarction, total occlusion of the vessel, vessel dissection, perforation, rupture or injury.

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 call Medtronic at 1-888-283-7868.

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