PTCA Dilatation Catheter
Indications, Safety, and Warnings
INTENDED USE/INDICATIONS FOR USE
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) 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.
The 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.
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 balloon rated 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 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.
The safety and effectiveness of this PTCA balloon catheter for the treatment of in-stent restenosis (ISR) has not been established.
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