What: After reporting success in two important trials, shares in Edwards Lifesciences (NYSE:EW) are jumping 17.3% higher at 11:30 a.m. today.
So what: The cardiac device medtech company reports that trials evaluating the use of its Sapien heart valve show that using the device in intermediate-risk patients resulted in similar efficacy as open-heart surgery.
Specifically, the rate of all cause mortality or stroke in Sapien patients was 19.3% versus 21.1% for open-heart surgery patients at the two-year mark. Patients receiving the Sapien XT transfemorally did even better, with an event rate of 16.3%.
Edwards Lifesciences also reports that transcatheter aortic valve replacement, or TAVR, with its Sapien 3 valve was superior to open-heart surgery in intermediate-risk patients.
Now what: The finding positions Edwards Lifesciences to significantly expand its addressable patient population. Currently, the Sapien XT and Sapien 3 are only approved by the FDA for use in high-risk patients with severe aortic stenosis (a narrowing of the aortic opening), which represents a small slice of the market. Intermediate-risk patients account for an estimated 30% to 40% of surgical aortic valve procedures.
Undeniably, this is good news for Edwards Lifesciences, especially given that its sales and profitability have already been climbing handsomely.
In Q4, net sales were $671.1 million, representing ex-currency growth of 15.1% versus the year prior. Net income in the quarter was $140.7 million, or $0.64 per diluted share.
The company's guidance for 2016 includes sales of between $2.6 billion and $2.85 billion, and EPS within a range of $2.57 to $2.67. These clinical findings could mean that guidance may prove to be conservative, so investors may want to keep this stock on a list of names to buy.