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.

Carpentier-Edwards PERIMOUNT Theon mitral valve
The Carpentier-Edwards PERIMOUNT Theon mitral valve is 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.

Carpentier-Edwards PERIMOUNT mitral valve
The Carpentier-Edwards PERIMOUNT mitral valve is intended for use in patients whose aortic or 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 aortic or 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.