USFDA approves Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058

Both of the sytems, the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO gets the USFDA approval. Both consists of a transcatheter aortic valve (TAV), a delivery catheter, and a loading system. The TAV being an artificial heart valve made of pig tissue attached to a flexible, self-expanding nickel-titanium (Nitinol) frame for support.

The TAV is compressed and mounted on the end of a tube-like device called a delivery catheter. Then it is inserted into the body through an artery in the leg, neck, or through a small cut between the ribs. The valve is then released from the catheter; and is anchored to the diseased valve. Once the new valve is in place, it functions the same as the old valve.

The products 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.

These should not be used in patients with a heart infection and cannot tolerate thinning of blood; has nitinol sensitivity.