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  1. Device Approvals, Denials and Clearances

Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033

Image of the devices.

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 System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System
PMA Applicant: Medtronic CoreValve LLC
Address: Medtronic CoreValve LLC, 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: 07/10/2017
Approval Letter: Approval Order

What is it? The Medtronic CoreValve family of devices is comprised of three design iterations: the Medtronic CoreValve System (1st generation), the Medtronic CoreValve Evolut R System (2nd generation); Medtronic CoreValve Evolut PRO System (3rd generation). Each system 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 family of devices was 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 high and greater risk for surgical therapy. This approval expands the indications for use to patients at intermediate 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, 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 at the correct time to force the blood to flow in the correct direction.

When is it used? The CoreValve family of TAVs is used in patients whose own aortic heart valve is 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, the heart 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 family of TAVs should only be used in patients who are at intermediate or greater risk from traditional open-heart surgery as determined by their heart team (a cardiologist and surgeon).

What will it accomplish? The CoreValve family of TAVs can improve blood flow in patients with a diseased aortic valve who need open-heart surgery but are considered to be at intermediate or greater risk for complications or death associated with the procedure. In the clinical study, the CoreValve family of TAVs was shown to be reasonably safe and effective for those patients without the need for open-heart surgery. The risk of death or disabling stroke at 2 years was similar in patients receiving a CoreValve TAV and those receiving open-heart surgery. However, implanting a CoreValve TAV also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, and complications with the arteries used to insert the valve. 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 this device.

When should it not be used? The CoreValve should not be used in patients who:

  • have an infection in the heart or elsewhere.
  • have an artificial (mechanical) aortic valve.
  • cannot tolerate blood thinning medicines.
  • have sensitivity to Nitinol (Titanium or Nickel) or fluid used during the procedure to see internal structures (contrast media).

Additional information (including warnings, precautions, and adverse events):

Other Resources: