MRI safety information MRI safety information

MRI safety

Heart valve products

US MRI safety information - heart valve products

Outside the US MRI safety information - heart valve products

Contact technical support

Contact the Edwards Lifesciences technical support department at 800-822-9837 (USA) or 949-250-2500 for any additional information regarding MRI safety of our products. Or, you may contact technical support online. If applicable, please include the implant model number in your request.

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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