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Thursday, July 10, 2014


Medtronic CoreValve System - P130021/S002

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
PMA Applicant: Medtronic CoreValve LLC
Address: Medtronic CoreValve LLC, 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: June 12, 2014
Approval Letter: cdrh_docs/pdf13/P130021S002a.pdf

What is it? The Medtronic CoreValve System (often referred to as the CoreValve) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of pig tissue attached to a flexible, self-expanding, nickel-titanium frame for support.

How does it work? The CoreValve is compressed and placed on the end of a tube-like device called a delivery catheter. It is then inserted through the femoral artery in the leg. If the femoral arteries are not suitable, the valve can also be inserted through other arteries or through the aorta. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then released from the catheter, it expands on its own, and anchors to the diseased valve. The CoreValve functions the same as a normal valve, helping the blood flow properly by opening and closing like a door to force the blood to flow in the correct direction.

When is it used? The CoreValve is 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, 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 the patients die within two years if the diseased valve is not replaced.

The CoreValve should only be used in patients who cannot undergo, or are at high risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).

What will it accomplish? The CoreValve can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but the surgical procedure is highly risky, or too risky. In the U.S. clinical trial, the CoreValve was shown to be reasonably safe and effective for those patients without the need for open-heart surgery. However, implanting the CoreValve also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, 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 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 to fluid used during the procedure to   see internal structures (contrast media).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.