This therapy is not for everyone.  Please consult your physician.  A prescription is required.  Careful and continuous medical follow-up is required so that device-related complications can be diagnosed and properly managed to minimize danger to the patient.

Edwards Lifesciences mitral stented porcine valves
The Edwards Lifesciences mitral stented porcine valves are intended for use in patients whose mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. It is also intended for use in patients with a previously implanted mitral valve prosthesis which is no longer functioning adequately and requires replacement.

Valve replacement can include the following risks:

• The device does not open properly
• Leakage (regurgitation) due to improper function of device (incompetence)
• Leakage resulting from areas surrounding the device (perivalvular leak)
• Infection of the heart (endocarditis)
• Damage to red blood cells that can result in anemia (hemolysis)
• Clots from the device break off and enter the bloodstream (thromboembolism)
• Clotting prevents function of the device (thrombotic obstruction)
• Bleeding disorders related to the use of anticoagulant therapy (blood thinners)
• Ventricular perforation by stent posts
• Looped sutures and malfunctions of the valve due to distortion at implant
• Fracture of the stent or physical or chemical deterioration of valve components
• Tissue deterioration which may result from infection, calcification, thickening perforation, degeneration, suture abrasion, instrument trauma, and leaflet detachment from the valve stent posts
• Abnormal heart sounds (murmur)
• Shortness of breath (dyspnea)
• Exercise intolerance
• Breathing difficulty particularly when lying down (orthopnea)
• Low red blood cell count (anemia)
• Fever
• Damaged conduction system (how the heart controls its beating, also known as arrhythmia)
• Abnormal bleeding
• Temporary neurologic dysfunction due to a stroke (transient ischemic attack)
• Stroke (cerebral vascular accident)
• Paralysis
• Low cardiac output (the heart does not pump enough blood)
• Fluid accumulation in the lungs (pulmonary edema)
• Heart failure
• Heart attack

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