Medtronic Inc., the Minnesota medical device maker that’s developing a new type of heart valve in Irvine, has gotten the regulatory go ahead for a key trial of the device.
The company’s Irvine-based CoreValve received Food and Drug Administration approval to study the valve in more than 1,200 patients at 40 U.S. sites.
The valve is inserted via a catheter and doesn’t require open heart surgery.
It’s seen as the closest rival to a similar valve from Irvine-based Edwards Lifesciences Corp. that has an early lead with a U.S. trial under way.
The catheter valves are seen as the biggest advancement in heart valves in years and could open up the market to millions of patients who aren’t candidates for getting their valves replaced via major surgery.
CoreValve’s trial is set study use of its valve in patients considered at high risk for open-heart surgery as well as those deemed an extreme risk.
Patients are set to get a catheter implant or a traditional valve via open-heart surgery to measure survivability rates in both groups.
Both Medtronic and Edwards already sell their catheter valves in Europe, where sales are small but fast growing.
Catheter valve sales in Europe are expected to be about $400 million this year with analysts forecasting them to become a multibillion-dollar annual market.
U.S. approval of Edwards’ valve is expected next year.
Medtronic’s valve has U.S. approval for use in a small amount of humanitarian cases with widespread approval not expected before 2014.
Medtronic entered the catheter valve market with its 2009 buy of Irvine’s CoreValve Inc. for $700 million.
The company employs about 650 people locally at a traditional heart valve plant in Santa Ana and at CoreValve in Irvine.
