Medtronic Hall^® Valve

Indications:

This device is indicated in the surgical treatment of cardiac valvular disease when implantation of a prosthetic heart valve is the treatment of choice. It may also be indicated as a replacement for a previously implanted prosthetic heart valve.

Contraindications:

Contraindicated for patients unable to tolerate long-term anticoagulation therapy.

Warnings/Precautions/Side Effects:

Valve dysfunction due to occluder impingement of any mechanical heart valve by any cause, may result in severe complications including patient death. Intravascular hemolysis may occur following implantation of this prosthesis in the aortic and/or mitral position. The level of this intravascular hemolysis increases with increasing valve size. Medtronic recommends anticoagulant therapy unless, for other reasons, it is not medically indicated. Possible side effects include, but are not limited to: infections, hemolysis, thromboembolic phenomena, dysrhythmias, valve dehiscence, prosthesis failure, high gradients, prosthesis thrombosis, bleeding, paravalvular leak and regurgitation.

For additional information, please refer to the Instructions For Use provided with the product.

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