FDA Approves Medtronic's CoreValve Heart Device

By Joseph Walker 

Medtronic Inc. received U.S. regulatory approval to sell its minimally invasive heart valve technology for patients too frail for traditional surgery, the medical device maker said Friday.

The U.S. Food and Drug Administration granted approval for CoreValve, used to replace damaged aortic valves, three months earlier than Medtronic had previously forecast. The approval allows the Minneapolis-based company to begin competing against rival Edwards Lifesciences Corp., whose similar device, called the Sapien, was first approved in the U.S. in 2011. The Sapien has since been approved for a wider range of patients, including those who are eligible for surgery, but who are considered at high risk for complications.

The CoreValve is approved for patients with severe aortic stenosis who are too sick or frail to undergo open-heart surgery, which is considered the standard of care for most patients. In a clinical trial, patients receiving the device had a 25.5% rate of death or major stroke after one year, compared with an estimated rate of 43% had the patients received medication therapy.

The technology, called transcathether aortic valve replacement--or TAVR--is used to implant new valves through a catheter tube inserted into a patient's artery. It is a less-invasive method compared with open surgery, which can be traumatic. However, open surgery is still considered the safest and most effective option for patients who can withstand it because of TAVR's increased risk of stroke and other complications.

Shares of Edwards Lifesciences fell 3.9% to $69.82 in midday trading on the New York Stock Exchange, with investors surmising that the early approval will allow Medtronic to take even more market share away from Edwards than previously estimated. The stock is down 23.6% over the past 12 months, hurt by disappointing U.S. sales of the Sapien. The company estimates that world-wide TAVR sales will be in a range of $700 million to $820 million in 2014.

Write to Joseph Walker at [e-mail]

Subscribe to WSJ: http://online.wsj.com?mod=djnwires