Maverick® PTCA Balloon Catheters

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

Maverick® Over-The-Wire Balloon Catheter
The Maverick Balloon Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Maverick Balloon Catheter (balloon models 2.25 mm - 4.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. NOTE: Bench testing was conducted with the Maverick Balloon Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to differences in stent design.

Maverick²'™ Monorail® Balloon Catheter
The Maverick² Balloon Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Maverick² Balloon Catheter (balloon models 2.25 mm - 4.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. NOTE: Bench testing was conducted with the Maverick² Balloon Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to differences in stent design.

Maverick® XL Monorail® Balloon Catheter
The Maverick XL Monorail Balloon Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for improving myocardial perfusion. The Maverick XL Monorail Balloon Catheter is 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

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 the 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. The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty. Before insertion of the dilatation catheter, administer appropriate anticoagulant and coronary vasodilator therapy.

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Potential Adverse Effects

Death; myocardial infarction; occlusion; coronary vessel dissection, perforation, rupture or injury; restenosis; hemorrhage or hematoma; unstable angina; arrhythmias; drug reactions, allergic reaction to contrast medium; hypo/hypertension; infection; coronary artery spasm; arteriovenous fistula; embolism.

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Cautions

Federal law restricts this product to sale by or on the order of a physician.

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Trademark

Maverick, Maverick², Monorail, LEAP, TrakTip, SoftLEAP, DynaLEAP and Bioslide are trademarks of Boston Scientific Corporation. Pebax is a trademark of Arkema France Corp.