Irvine-based heart valve maker Edwards Lifesciences Corp. reported what it called positive results from two studies of a new type of valve that doesn’t require major surgery.
Shares of Edwards closed up 12% Monday on a market value of $3.1 billion. The gain was driven by the valve study results and a 10%-plus rebound surge for the major Wall Street stock indexes.
The company said one European study found a 94% survival rate at 30 days of after receiving Edwards’ Sapien valve, which is inserted via a catheter.
The study was based on European use of the valve since being approved there late last year. A U.S. clinical trial continues with potential approval by 2011.
A second European study showed a 92% survival rate at 30 days and 90% percent at six months.
Sapien has been a big driver of Edwards’ stock this year.
In summer, it prompted speculation that a bigger medical device maker may want to acquire Edwards.
The company is seen as having a two-year lead on the development of a catheter valve.
Then in August, Edwards shares slumped after an analyst forecast higher than expected risk of deaths from the Sapien valve.
Sapien and similar products are seen as the biggest development in heart valves in years. They are inserted via a catheter through a vein in the leg or through the ribs, instead of during open-heart surgery.
Catheter valves are seen as broadening the market to patients too old or sick for major surgery.
Edwards got into the catheter valve market in 2003 when it spent $125 million for Percutaneous Valve Technologies Inc. of New Jersey.
Sapien could be big for Edwards. Analysts and industry figures have estimated the market for catheter valves could reach $1 billion within 10 years of their launch.
For now, Sapien is small. The valve had about $13 million in European sales in the second quarter.
Edwards’ total sales for 2008 are forecast at $1.3 billion.
