Sprinter OTW

Indications, Safety, and Warnings

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^®, Sprinter^® (balloon models 2.5 mm to 4.0 mm), Sprinter Legend (balloon models 2.25 mm to 4.0 mm) and NC Sprinter (balloon models 2.25 mm to 5.0 mm) balloon dilatation catheters are also indicated for the post-delivery expansion of balloon expandable stents. (Note: Bench testing was conducted with the NC Stormer, Sprinter, Sprinter Legend and NC 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 significant 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: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.