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
Manufacturer: Medtronic CoreValve LLC
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: January 17, 2014
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf13/P130021a.pdf
What is it? The main component of the Medtronic CoreValve System is an artificial aortic valve (often referred to as the CoreValve) implanted through a delivery catheter. The CoreValve is made of natural tissue obtained from the heart of a pig. The valve is attached to a flexible, self-expanding Nitinol (nickel-titanium) frame for support and it comes in four sizes: 23 mm, 26 mm, 29 mm, and 31 mm.
How does it work? The CoreValve is compressed and put on the end of a delivery catheter which is a tube-like device. The delivery catheter is then inserted into the body by way of the artery in the leg, the artery below the collar bone that carries blood to the arm, or through a small cut between the ribs. The catheter is pushed through the blood vessels until its far end reaches the damaged natural aortic valve. The valve is then released from the end of the catheter and expands on its own so it holds on (anchors) to the diseased valve. Once the new valve is in place, it functions the same as the old valve. It helps the blood flow properly by 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 is used in patients whose aortic heart valve is damaged due to calcium build up and cannot open and close properly, so blood is not able to flow efficiently. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak, which 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.
The CoreValve should only be used in patients who either cannot undergo open heart surgery to have their aortic valve replaced, or in patients who are at extreme risk of death from traditional open-heart surgery to replace the valve; as determined by their heart team (a cardiologist and surgeon).
What will it accomplish? Implantation of the CoreValve can help restore normal blood flow in patients with severe aortic stenosis who need open-heart surgery to replace the diseased valve, but for whom such a procedure is too risky. Any procedure to replace the aortic valve carries the risk for serious complications. In the clinical trial of the device, the major risks observed included death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, and the need for a permanent pacemaker. These risks may be relatively high for some patients with coexisting conditions or diseases.
The CoreValve may be a very good alternative for some patients whose heart team determines the risks associated with an open (invasive) surgery are extremely high. Patients should discuss the CoreValve’s benefits and risks with their doctors.
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 (nickel or titanium ) or contrast media (fluid used during the procedure to see internal structures).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.