This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System
PMA Applicant: Medtronic CoreValve LLC
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: August 16, 2019
Approval Letter: Approval Order
What is it? The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System each consists of a transcatheter aortic valve (TAV), a delivery catheter, and a loading system. The TAV is an artificial heart valve made of pig tissue attached to a flexible, self-expanding nickel-titanium (Nitinol) frame for support.
The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System were previously approved for the treatment of severe aortic stenosis (a narrowing of the aortic valve that restricts blood flow to aorta, the body's main artery) in patients at intermediate and greater risk for surgical therapy. This approval expands the indications for use to patients at low risk for surgical therapy.
How does it work? The doctor compresses the TAV and mounts it on the end of a tube-like device called a delivery catheter. The TAV is then inserted into the body through an artery in the leg, the artery in the neck, or through a small cut between the ribs. The valve is then released from the catheter; it expands on its own, and anchors to the diseased valve. Once the new valve is in place, it functions the same as the old valve, opening and closing like a door to force the blood to flow in the correct direction.
When is it used? The CoreValve Evolut R and CoreValve Evolut PRO TAVs are used in patients whose own aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, it eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. Once symptoms of severe aortic stenosis occur, over half of patients die within two (2) years if the diseased valve is not replaced.
The CoreValve Evolut R and CoreValve Evolut PRO TAVs should only be used in patients who are considered appropriate for transcatheter heart valve replacement therapy by their heart team (including a surgeon).
What will it accomplish? The CoreValve Evolut R and CoreValve Evolut PRO TAVs can improve blood flow in patients with aortic stenosis. In the clinical study, the two TAVs were shown to be reasonably safe and effective for treating patients with severe aortic stenosis without the need for open-heart surgery. The risk of death or disabling stroke at 2 years was similar in patients receiving a CoreValve Evolut R or CoreValve Evolut PRO TAV and those receiving open-heart surgery.
Any procedure to replace the aortic valve carries the risk for serious complications. The serious complications associated with implanting a CoreValve Evolut R or CoreValve Evolut PRO TAV also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. For some patients with coexisting conditions or diseases, the risks may be especially high.
Patients should discuss with their doctors the benefits and risks of these two devices.
When should it not be used? The CoreValve Evolut R System and CoreValve Evolut PRO System should not be used in patients who:
- have an infection in the heart or elsewhere.
- cannot tolerate blood thinning medicines.
- have sensitivity to Nitinol (Titanium or Nickel).
Additional information (including warnings, precautions, and adverse events):