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European Regulators Approve New Use for Medtronic’s Irvine-Developed Heart Valve

Medtronic Inc., a Minnesota device maker with an estimated 675 workers in Irvine and Santa Ana, said Thursday that European regulators approved a new usage for its replacement heart valve for treating patients with severe aortic stenosis, or narrowing arteries.

Medtronic’s CoreValve, which was developed in Irvine, received the CE mark, which allows it to be sold in countries throughout Europe, to be inserted through an artery in the collar bone. Medtronic already had approval to insert it through the femoral artery in the leg.

The diversified device maker got CoreValve through a $700 million deal for Irvine startup CoreValve Inc. in 2009.

CoreValve’s inserted through a catheter, eliminating the need for open heart surgery or surgical removal of a patient’s original valve.

Medtronic is chasing Irvine-based Edwards Lifesciences Corp. in the race to get less-invasive heart valves to market in the United States.

Edwards’ Sapien valve, which is also sold in Europe, is in a clinical trial with an eye toward possible Food and Drug Administration approval at the end of 2011 or beginning of 2012.

CoreValve isn’t expected to be available in the U.S. until around the middle of the decade.

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