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INSPIRIS RESILIA aortic valve

Indications: For use in replacement of native or prosthetic aortic heart valves.

Contraindications (Who should not receive): There are no known contraindications with the use of the INSPIRIS RESILIA aortic valve.

Complications and Side Effects: The risks with the INSPIRIS RESILIA aortic valve are similar to risks with other heart valves, and include the following:

• Heart failure
• Leaking from the valve or areas around the valve
•  Improper opening and closing of the valve
• Damage to red blood cells that can result in low red blood cell count
• Heart lining inflammation
• Heart infection
• Abnormal bleeding or bleeding problems from using blood thinners
• Clots from around the valve or other areas of the heart entering the bloodstream and blocking blood flow
• Heart attack
• Heart rhythm problems that may lead to the need for implanting a permanent pacemaker, a device that helps your heart beat in regular rhythm
• Allergic reaction to the materials in the valve

These could lead to the need for reoperation to replace the valve, permanent disability, or death.

This is not a complete list of all the risks that can occur with heart valve surgery. Your doctor can give you more information about these and other risks. This information is not a substitute for talking with your doctor.

MITRIS RESILIA mitral valve

Indications: For use in replacement of native or prosthetic mitral heart valves.

Contraindications (Who should not receive): There are no known contraindications with the use of the MITRIS RESILIA mitral valve.

Complications and Side Effects: The risks with the MITRIS RESILIA mitral valve are similar to risks with other heart valves, and include the following:

• Heart failure
• Leaking from the valve or areas around the valve
• Improper opening and closing of the valve
• Damage to red blood cells that can result in low red blood cell count
• Heart lining inflammation
• Heart infection
• Abnormal bleeding or bleeding problems from using blood thinners
• Clots from around the valve or other areas of the heart entering the bloodstream and blocking blood flow
• Heart attack
• Heart rhythm problems that may lead to the need for implanting a permanent pacemaker, a device that helps your heart beat in regular rhythm
• Injury could occur to the heart tissue or blood flow could be blocked
• Allergic reaction to the materials in the valve

These could lead to the need for reoperation to replace the valve, permanent disability, or death.

This is not a complete list of all the risks that can occur with heart valve surgery. Your doctor can give you more information about these and other risks. This information is not a substitute for talking with your doctor.

KONECT RESILIA aortic valved conduit

Indications: For use in replacement of native or prosthetic aortic heart valves and the associated repair and replacement of a damaged or diseased ascending aorta.

Contraindications (Who should not receive): There are no known contraindications with the use of the KONECT RESILIA aortic valve conduit.

Complications and Side Effects: The risks with the KONECT RESILIA aortic valve conduit are similar to risks with other heart valves, and include the following:

• Heart failure
• Leaking from the valve or areas around the valve
• Improper opening and closing of the valve
• Damage to red blood cells that can result in low red blood cell count
• Heart lining inflammation
• Heart infection
• Abnormal bleeding or bleeding problems from using blood thinners
• Clots from around the valve or other areas of the heart entering the bloodstream and blocking blood flow
• Heart attack
• Heart rhythm problems that may lead to the need for implanting a permanent pacemaker, a device that helps your heart beat in regular rhythm
• Allergic reaction to the materials in the valve or graft
• Graft infection
• Ballooning and weakening of an area in an artery
• Blood collecting between the layers of an artery
• Fluid buildup under the surface of the skin
• Fluid buildup around the graft
• Blockage of a blood vessel
• New tissue growth on the graft
• Enlargement of the graft

These could lead to the need for reoperation to replace the valve, permanent disability, or death.

This is not a complete list of all the risks that can occur with heart valve surgery. Your doctor can give you more information about these and other risks. This information is not a substitute for talking with your doctor.

CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.