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: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: March 30, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/p130021S010a.pdf
What is it? The Medtronic CoreValve System consists of a transcatheter aortic valve (referred to as the CoreValve), a delivery catheter, and a compression loading system. The CoreValve It is made of natural tissue obtained from the heart of a pig and attached to a flexible, self-expanding, nickel-titanium (Nitinol) frame for support.
How does it work? The doctor first compresses the CoreValve and mounts it on the end of a tube-like device called a delivery catheter. The catheter is inserted into the body through an artery in the leg, an artery in the neck, or through a small cut between the ribs. It is further pushed through the blood vessels until it reaches the failed tissue aortic valve. The CoreValve is then released from the end of the catheter and expands on its own so it anchors to the failed valve. Once the new valve is in place, it opens and closes properly guiding the blood to flow in the correct direction.
When is it used? The CoreValve is used in patients whose previously implanted tissue aortic valve has become narrowed, leaky, or both, so blood is not able to flow efficiently. As the heart works harder to pump enough blood, 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.
The CoreValve should only be used in patients who are at high or extreme risk of death from traditional open-heart surgery to replace the failed valve as determined by their heart team (a cardiologist and surgeon).
What will it accomplish? The CoreValve can help improve blood flow in patients with a failed tissue aortic valve who need open-heart surgery to replace the failed heart valve, but the procedure is highly or extremely risky. Any procedure to replace the aortic valve carries the risk of serious complications. In the clinical trial of 143 patients, the estimated rate of survival without major stroke was 95.8% at 30 days and 89.3% at six months.
The major risks observed in the clinical trial 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.
Patients should discuss the risks and benefits of this device 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 in their body.
- have an artificial (mechanical) aortic valve.
- cannot tolerate blood thinning medicines.
- have sensitivity to titanium or nickel (Nitinol) 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.
