NC QUANTUM APEX™
PTCA Dilatation Catheter
Indications, Safety and Warnings
Prior to use, please see the complete "Directions for Use" for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instructions.
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
INTENDED USE/ INDICATIONS FOR USE
The NC Quantum Apex Over-The-Wire and NC Quantum Apex Monorail™ PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
NC Quantum Apex Over-The-Wire and NC Quantum Apex Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
Note: Bench testing was conducted with NC Quantum Apex Over-The-Wire and NC Quantum Apex Monorail PTCA Dilatation Catheters and marketed Boston Scientific balloon catheter expandable stents. Consideration should be taken when this device is used with different manufacturers’ stents due to differences in stent design.
- 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 premedicated.
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.
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:
- abrupt closure
- acute myocardial infarction
- angina or unstable angina
- arrhythmia, including ventricular fibrillation
- arteriovenous fistula
- cardiac tamponade/pericardial effusion
- cardiogenic shock
- cerebrovascular accident/stroke
- coronary aneurysm
- coronary artery bypass graft surgery
- coronary artery spasm
- coronary vessel dissection, perforation, rupture or injury
- drug reactions, allergic reaction to contrast medium
- hemodynamic compromise
- hemorrhage or hematoma
- minor vessel trauma
- myocardial ischemia
- percutaneous re-intervention
- pseudoaneurysm (at site of catheter insertion)
- pyrogenic reaction
- renal failure
- respiratory insufficiency
- restenosis of the dilated vessel
- side branch occlusion
- slow flow/no reflow
- total occlusion of the coronary artery or bypass graft
- transient ischemic attack
- vasovagal reactions
- ventricular irritability/dysfunction
- vessel trauma requiring surgical repair or intervention
- volume overload