CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Information contained herein is for distribution outside the U.S., France & Japan only. Illustrations for information purposes—not indicative of actual size or clinical outcome.
INTENDED USE/INDICATIONS FOR USE:
The NC Emerge OTW and NC Emerge MR 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 in patients with atherosclerosis. The NC Emerge OTW and NC Emerge MRPTCA Dilatation Catheters (balloon models 2.00- 5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).
NOTE: Bench testing was conducted with NC Emerge OTW and NC Emerge MR PTCA Dilatation Catheters and marketed Boston Scientific balloon expandable stents. Consideration should be taken when this device is used with different manufacturers’ stents due to differences in stent design. All stents should be deployed in accordance with the manufacturer’s indications and instructions for use.
The NC Emerge PTCA Dilatation Catheter is contraindicated for use in:
- 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 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 advance or retract the catheter unless the balloon is fully deflated under vacuum.
- Do not exceed the balloon rated burst pressure.
- If difficulty is experienced during balloon inflation, do not continue; remove the catheter.
- Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy.
- Balloon catheter retrieval methods (use of additional wires, snares, and/or forceps) may result in trauma to the treated vessel and/or the vascular access site. Complications can include but are not limited to bleeding, hematoma, or pseudoaneurysm.
- The compatibility of the device has not been evaluated for the delivery of materials (e.g. alcohol or nitroglycerine, stem cells, etc.) 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.
- Before insertion of the balloon catheter, administer appropriate anticoagulant and coronary vasodilator therapy.
- Do not expand the balloon if it is not properly positioned in the vessel.
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, possibly requiring surgical repair or intervention
- drug reactions, including allergic reaction to contrast medium
- hemodynamic compromise
- hemorrhage or hematoma
- minor vessel trauma
- myocardial ischemia
- percutaneous re-intervention
- pseudoaneurysm (at vascular access site)
- 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 reaction
- ventricular irritability/dysfunction
- vessel trauma requiring surgical repair or intervention
- volume overload