 | | | | | Repair valve | | | Replace aortic valve | | | Replace mitral valve | |
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Edwards Lifesciences Heart Valve Therapy Disclaimer
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 Magna aortic valve
The Carpentier-Edwards PERIMOUNT Magna aortic valve is intended for use in patients whose aortic 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 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 Theon aortic valve
The Carpentier-Edwards PERIMOUNT THEON aortic 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.
Carpentier-Edwards PERIMOUNT aortic valve
The Carpentier-Edwards PERIMOUNT aortic 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.
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