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.
Todd Campbell has no position in any stocks mentioned. Todd owns E.B. Capital Markets, LLC. E.B. Capital's clients may have positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.