Edwards wins FDA nod to expand Sapien label

The FDA has expanded the label for Edwards Lifesciences' Sapien valve, indicating it for inoperable patients.--Courtesy of Edwards Lifesciences

While ired investors mount lawsuits over scaled-back sales projections, Edwards Lifesciences ($EW) has carved out a larger market for its banner heart valve, winning FDA approval to use Sapien on inoperable patients.

The FDA's earlier approval covered transfemoral and transapical implantations of Sapien, but the new label removes any reference to delivery method, the agency said, making the device available to the roughly 30% of aortic valve stenosis patients deemed inoperable.

That means more patients will be eligible for Sapien's life-saving benefits, the FDA said, and, from Edwards' perspective, expanding its patient population could lead to a more robust 2013.

Just how much the latest label will affect sales and whether Edwards will update its guidance remains unknown, and the company declined to comment on its revenue outlook Monday.

Back in the winter, just months after Edwards convinced the FDA to indicate Sapien for high-risk patients, the company projected 45% annual growth for the implant, counting on pent-up U.S. demand to bring in $790 million for 2013.

That didn't quite work out in the first quarter, and Edwards slashed its full-year expectations for Sapien by about 9.5% in April, spooking investors and pillorying its stock price in the process.

Now the California devicemaker is facing a bevy of lawsuits from investors claiming Edwards knowingly withheld information about soft demand for Sapien but trumped up revenue projections to inflate its shares.

Despite the rough spring, Edwards has been piecing together some shareholder confidence over the past few months, winning Japanese approval and reimbursement for the Sapien XT valve and beating out rival Medtronic ($MDT) in a German patent dispute.

But investors aren't exactly quick to forget: Last time Edwards expanded Sapien's label, its shares hit an all-time high of $110.79; after Monday's news, the company stayed about flat at $70.

- read the FDA announcement