Apex® PTCA Dilatation Catheter

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

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Indications

The Apex Over-the-Wire and Apex Monorail® PTCA Dilatation Catheters (balloon models 1.50mm-5.00mm) 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 2.00mm-5.00mm) are also indicated for the post-delivery expansion of balloon expandable stents.

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Contraindications

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

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Warnings

General Warnings: This product contains no detectable latex. • 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. • 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.

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Potential Adverse Effects

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 • Anxiety/pain • 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 • Death • Drug reactions, allergic reaction to contrast medium • Embolism • Hemodynamic compromise • Hemorrhage or hematoma • Hypotension/hypertension • Infection • Minor vessel trauma • Myocardial ischemia • Percutaneous re-intervention • Phlebitis • Pseudoaneurysm (at site of catheter insertion) • Pyrogenic reaction • Renal failure • Respiratory insufficiency • Restenosis of the dilated vessel • Side branch occlusion • Slow flow/no reflow • Thrombosis • 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.

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Precautions

General Precautions: The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.

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Caution:

Federal (USA) law restricts this device to sale by or on the order of a physician.