Shares of Irvine, CA-based heart device specialist Edwards Lifesciences (EW) flew 17% in Monday trading after unveiling clinical trial data showing that a procedure using its heart valve device Sapien 3 was superior to open heart surgery for some patients. The stock closed at an all time high of $105.03.
The Sapien 3 is already approved for high-risk patients (aka those for whom open heart surgery is inadvisable) with aortic valve stenosis, or a narrowing of the aortic valve due to calcium buildup. But Edwards has been trying to expand the market by winning a label expansion for intermediate-risk patients.
Results revealed at the American College of Cardiology conference on Sunday are certain to bolster the firm’s case for a broader indication. So-called TAVR procedures performed with Sapien 3 led to lower rates of mortality and stroke compared with surgery, even while maintaining equal (or even superior) performance.
The results led some medical experts at the conference to declare that Edwards’ device would eventually become the go-to treatment option for aortic stenosis patients.
Edwards has said that it hopes for an FDA approval for intermediate-risk patients by the end of the year.
While Monday trading set a new ceiling for the company, Edwards has been on a rip over the past several years. It experienced 13% revenue growth and a 117% spike in earnings-per-share in 2015 compared to the previous year. In February, the company raised its full-year 2016 earnings guidance in anticipation of burgeoning sales of Sapien 3.