Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
The Emerge Over-The-Wire and Emerge Monorail™ PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Unprotected left main coronary artery. Coronary artery spasm in the absence of a significant stenosis.
PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA as treatment of this patient population carries special risk. Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Use extreme caution and careful judgment in patients who have severe reaction to contrast agents that cannot be adequately pre-medicated. PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication. To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate, or be less than, the diameter of the vessel just proximal and distal to the stenosis.
The compatibility of the device has not been evaluated for the delivery of materials (e.g., drugs, alcohol, or stem cells) through the guidewire lumen, other than those required for normal use. The balloon catheter should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.
Potential adverse events (in alphabetical order) that may be associated with the use of a PTCA Dilatation Catheter include, but are not limited to, the following:
Federal Law (USA) restricts this device to sale by or on the order of a physician.