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Important safety information

Important safety information

Important Safety Information: Carpentier-Edwards PERIMOUNT Aortic Bioprostheses

Indications: For use in patients whose aortic valvular disease warrants replacement of their natural or previously placed prosthetic valve.

Contraindications: Do not use if surgeon believes it would be contrary to the patient’s best interests.

Complications and side effects: Stenosis, regurgitation, endocarditis, hemolysis, thromboembolism, valve thrombosis, nonstructural dysfunction, structural valve deterioration, anemia, arrhythmia, hemorrhage, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, angina, any of which could lead to reoperation, explantation, permanent disability, and death.

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. See instructions for use for full prescribing information.

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