Shares of Irvine-based Edwards Lifesciences Corp. shot up Thursday on positive trial results for a new type of heart valve and regulatory approval for further study of the device.
Edwards’ stock closed up 13% with a market value of $7.7 billion.
The product, Sapien, is a replacement heart valve that’s inserted via a catheter.
Sapien and competing devices are seen as the biggest advances in heart valves in years and could open up the market to millions of patients who aren’t candidates for major surgery.
The New England Journal of Medicine published test results from an initial Sapien study that showed that the valve significantly reduced the rates of death from any cause in the patients it was implanted in.
The death reduction came in patients who had aortic stenosis, or a narrowing of the valve that connects the heart to the body’s biggest artery.
Meanwhile, Edwards said the Food and Drug Administration conditionally approved a second randomized, controlled study for Sapien.
That trial’s expected to take place sometime next year.
Analyst Duane Nash of Los Angeles-based Wedbush Securities said in a client note that the test results were encouraging.
He cautioned that the true test would come with a clinical trial showing how patients with Sapien fare compared to “higher-risk surgery.”
The first trial also showed a higher risk of strokes and vascular complications in patients who got Sapien.
Even with that, Larry Biegelsen, a Wachovia medical device analyst, wrote that the stroke risk was unlikely to prevent the valve from becoming “a new standard of care” for patients who don’t have other options and that the results would improve over time as surgeons perfected implanting techniques.
