The device has been developed to treat patients with severe aortic stenosis, who are at high risk for surgery.

The CoreValve System has offered low rates of procedural complications, including stroke, one of the most concerning complications of valve replacement because it can affect survival and quality of life.

Without open-heart surgery and without surgical removal of the diseased valve, the CoreValve System replaces a diseased aortic heart valve through a minimally invasive procedure.

The device will be inserted through an artery in the leg or upper chest, and then guided through the arteries into the heart.

Once the device is placed, the system expands and takes over the original valve’s function to enable oxygen-rich blood to flow efficiently out of the heart.

Medtronic Catheter Based Therapies general manager Rhonda Robb said, "The CoreValve System demonstrated exceptional clinical outcomes during the U.S. pivotal trial."

El Camino Hospital interventional cardiologist James Joye said the recent FDA approval of the CoreValve System is a significant milestone for patients with severe aortic stenosis who previously had no other treatment options.

"We are proud to have been one of the only community hospitals in the nation to participate in the groundbreaking clinical results that led to this approval," Joye added.