PTCA Dilatation Catheter
Indications, Safety and Warnings
INTENDED USE/INDICATIONS FOR USE
The Apex Over-The-Wire and Apex Monorail PTCA Dilatation Catheters (balloon models 1.5 mm-5.0 mm) are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
The Apex Over-The-Wire and Apex Monorail PTCA Dilatation Catheters (balloon models 2.0 mm-5.0 mm) are also indicated for the post-delivery expansion of balloon expandable stents.
- 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 judgement in patients whom anticoagulation is not indicated.
Use extreme caution and careful judgement 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.
Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
Catheter Placement and Removal
Do not exceed the rated balloon burst pressure.
The compatibility of the device has not been evaluated for the delivery of materials (e.g. drugs, alcohol, or stem cells) through the guide wire lumen, other than those required for normal use.
The balloon catheter system 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