Emerge™ Monorail Over-The-Wire PTCA Dilatation Catheter

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

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 (balloon models 1.50-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-5.00 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 (balloon models 2.00-4.00 mm) and Emerge Monorail PTCA 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).

CONTRAINDICATIONS

• Unprotected left main coronary artery.
• Coronary artery spasm in the absence of a significant stenosis.

WARNINGS

• 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.
• When the catheter is exposed to the vascular system, it should only be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated and under vacuum. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
• Do not exceed the rated balloon burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9 percent of the balloons (with 95 percent confidence) will not burst at or below their rated burst pressure. A pressure monitoring device is recommended during use to prevent over-pressurization.
• If difficulty is experienced during balloon inflation, do not continue; remove the catheter.
• Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
• Before withdrawing the balloon catheter, visually confirm complete balloon deflation by fluoroscopy.

PRECAUTIONS

• 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.
• Prior to angioplasty, the balloon catheter should be examined to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.
• Care should be taken to control the position of the guide catheter tip during manipulation of the balloon catheter.
• Caution should be taken not to overtighten a hemostatic adapter around the catheter shaft as lumen constriction may occur, affecting inflation/deflation of the balloon.
• When loading or exchanging the balloon catheter, it is recommended to thoroughly wipe the guidewire clean for better catheter movement on the guidewire.
• Do not expand the balloon if it is not properly positioned in the vessel.
• In the case of simultaneous use of two EmergeTM balloon catheters in one guide catheter, care should be taken when introducing, torqueing, and removing guide wires and balloon catheters to avoid entanglement.

POTENTIAL ADVERSE EVENTS

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, slow flow/no reflow
• arrhythmia, including ventricular fibrillation or heart block
• bleeding, hemorrhage or hematoma
• cardiac arrest/cardiogenic shock
• cardiac tamponade/pericardial effusion
• cerebrovascular accident (stroke or transient ischemic attack)
• death
• drug reactions including allergy
• embolism (air, tissue, device fragments, plaque)
• hemodynamic compromise including vasovagal reaction
• infection
• myocardial ischemia or infarction
• organ insufficiency/failure (heart, lung, kidney)
• pain (angina)
• prolonged procedure time including additional intervention or surgery
• radiation injury
• restenosis of the dilated vessel
• thrombosis
• vessel injury (spasm, dissection, perforation, rupture, arteriovenous fistula, pseudoaneurysm)