Positive Clinical Trial Results Send Edwards Lifesciences UpOriginally published January 31, 2012 at 12:50 p.m., updated January 31, 2012 at 4:51 p.m.
Irvine-based heart valve maker Edwards Lifesciences Corp.'s shares rose today on positive test results for its new less-invasive valve.
Shares of Edwards were up 6% in early afternoon New York trading to a market value of about $9.5 billion.
Edwards said late Monday that results from a clinical trial of its Edwards Sapien less-invasive heart valve reduced the mortality rates in patients who have severe aortic stenosis, or a narrowing of the body’s primary artery.
Edwards said that mortality results were improved when patients in a non-randomized, continued access protocol of the clinical trial had Sapien implanted through the ribs. The device maker said that data was compared to results of patients treated through the rib implant approach in the trial’s randomized portion.
Edwards received Food and Drug Administration approval last year for Sapien when inserted through the femoral artery on patients who aren’t open-heart surgery candidates. It’s awaiting regulatory approval of Sapien for those patients who also are at high risk from standard surgery. The approval would include an approach where a surgeon pierces the ribs and puts the valve directly in place.