Important risk information

Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.

Indication:

Edwards transcatheter aortic heart valves are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are determined by qualified practitioners to be at specific risk for open surgical therapy. Patients should talk with their physicians to determine whether they are eligible for the transcatheter heart valve procedure and which transcatheter heart valve may be appropriate for them.

Contraindications (Who should not use):

Transcatheter aortic valve implantation (TAVI) should not be performed on patients who:

Cannot tolerate medications that thin the blood or prevent blood clots from forming.
Have an active infection in the heart or elsewhere.
Are allergic to the materials in some valves

Warnings:

There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are allergic to chromium, nickel, molybdenum, manganese, copper, silicon, and/or polymeric materials.
It is possible a TAVI valve may not last as long in patients whose bodies do not process calcium normally.
During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
Your doctor may determine that you should take medications that thin the blood or prevent blood clots from forming, except when likely to have an adverse reaction. There has not been testing on these devices for use without medications that thin the blood or prevent blood clots from forming.

Precautions:

The long-term durability of the transcatheter heart valves is not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing.

The safety and effectiveness of the transcatheter heart valve is also not known for patients who have:

An aortic heart valve that is not calcified, contains only one or two leaflets, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
Previous prosthetic ring in any position.
Previous atrial septal occlude.
A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
Diseased, abnormal or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for associated delivery devices, or a large amount of calcification at the point of entry.
Allergies to blood-thinning medications or dye injected during the procedure.
For a valve in valve procedure, there is a risk of leakage if the previously implanted tissue valve is not securely in place or if it is damaged. There is also the possibility that a partially detached valve leaflet from the previously implanted valve could block a blood vessel.
Additional pre-procedure imaging will be completed to evaluate proper sizing.

Potential risks associated with the procedure include:

Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
Risks to the heart, including heart attack or heart failure, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis(narrowing), too much fluid around the heart, injury to the structure of the heart.
Risks to your lungs or breathing, including difficulty breathing, fainting, buildup of fluid in or around the lungs, weakness or inability to exercise.
Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin.
Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection or bleeding at incision sites, or swelling.

Additional potential risks specifically associated with the use of the heart valve include:

Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery and possible removal of the TAVI valve, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), nonstructural valve dysfunction (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage, etc.) or mechanical failure of the delivery system and/or accessories.

CAUTION: These devices are restricted to sale by or on the order of a physician.