BENEFITS AND RISKS TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)

BENEFITS AND WHAT TO EXPECT FROM TAVR

You should start feeling better right away. This is because your heart valve is now working properly. Some patients may take longer to feel better. Many Medtronic TAVR patients report benefits like:

• Having more energy
• Being able to do everyday activities
• Breathing normally
• Experiencing less pain
• Feeling less anxious

TRANSCATHETER AORTIC VALVE REPLACEMENT RISKS

Most medical procedures have risks. The most serious transcatheter aortic valve replacement risks include:

• Death
• Stroke
• Serious damage to the arteries
• Serious bleeding
• Need for a new permanent pacemaker

The Medtronic TAVR valve should NOT be used for patients who:

• Have an infection
• Have a mechanical valve
• Cannot take blood thinning medicines
• Have a reaction to some metals
• Have a reaction to some imaging solutions

WARNINGS

Some patients may have a disease that results in more calcium in their blood. This may cause early wear.

The Medtronic TAVR valve is only for certain patients. This includes patients with severe aortic stenosis (AS) or failing surgical valves who:

• Are at intermediate risk or greater for surgery

PRECAUTIONS

• At some point the Medtronic TAVR valve may need to be replaced. How long it lasts varies from patient to patient.
• The Medtronic TAVR valve has been tested to mimic 5 years of use without failure. Keep appointments with your doctor. Follow all care instructions to ensure the best possible results.
• Antibiotics are recommended for patients who are at risk of infections.
• Patients should stay on blood-thinning medicines after the procedure as instructed. Patients who do not are more likely to have a stroke.
• If you require an MRI scan, tell the doctor you have a Medtronic TAVR valve. Tell your doctor if you have a Medtronic TAVR valve inside a surgical valve. Not doing so could result in injury or death. Your dentist and all doctors need to know about your Medtronic TAVR valve.

The Medtronic TAVR valve has not been studied in patients:

• Who are not sick from aortic stenosis
• Who are children
• With an aortic valve that has only one or two leaflets
• Who have a blood clot
• With an abnormal growth in the heart or arteries
• Who have an infection
• Who have AS in their own valve and a condition that allows blood to leak backwards through the aortic valve
• With poor left ventricle function
• Whose diseased valve is too small or too big
• Whose arteries are too small for the device
• Whose arteries that deliver blood to the heart may be blocked by the device
• Whose arteries that deliver blood to the heart need to be treated
• Whose arteries that deliver blood to the brain need to be treated
• Who have severe problems with bleeding or blood clotting
• Who have specific types of surgical valves implanted in the pulmonary valve
• Who have specific types of surgical valves implanted in the mitral valve
• Who have thick heart muscles making it difficult for the heart to pump blood
• Who have thick heart muscles that block the heart from pumping blood

If the Medtronic TAVR heart valve is used in these patients, it may not work properly. This could make you feel very sick or even cause death.

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