Edwards Lifesciences' received clearance from the Food and Drug Administration for expanded indications of two of its most popular products.
The Sapien 3 and Sapien XT transcatheter aortic valve replacements can now be used for patients with an intermediate risk of death or complications during open heart surgery. The valves — implanted via a catheter in a minimally invasive procedure — were previously only approved for high-risk patients..
The FDA based its approval on results released in April of a clinical trial involving intermediate-risk patients. Individuals who received a valve replacement via the company's TAVR implantation system had a significantly lower death and stroke rate than those who underwent surgical implantation.
The TAVR line of products already accounts for more than half of Edwards' revenue. Analysts expect the additional approval to increase the Irvine, Calif.-based company's addressable market by 50 percent.