FDA OKs Heart Valve Repair Test

Cardiovascular device maker Edwards Lifesciences Inc. on Thursday said it had received conditional approval from the Food and Drug Administration to start its trial testing a minimally invasive procedure to replace the aortic valve.

Irvine-based Edwards also reported fourth-quarter earnings, which rose to $25.9 million, or 42 cents a share, from $18.9 million, or 31 cents.

Excluding items, the No. 1 maker of heart valves earned 46 cents a share. On that basis, the consensus estimate on Wall Street was for a profit of 45 cents.

The new heart valve approach being tested by the company is less invasive than traditional treatment and could represent a big opportunity for the company, though it is still far from the market, analysts said.

The company said it hoped to get the product to market in three to four years.

Currently, replacing or repairing heart valves involves open-heart surgery. With Edwards’ new procedure -- with its so-called Cribier-Edwards Percutaneous Aortic Heart Valve -- the replacement or repair is done by a catheter, which is fed to the area through a blood vessel.

Edwards said it would conduct an initial feasibility study of 20 patients at high risk for conventional heart valve surgery.

Edwards backed Wall Street’s consensus estimate of 45 cents for the first quarter and $1.85 to $1.95 for the full year, excluding the effect of an accounting change to expense stock options.