fda there is no easy road

Take a look at how many devices they have transplanted and they are still losing money. Investors took a dim view of Thoratec Corp.'s earnings and future prospects Thursday, sending shares down 13 percent after the Pleasanton maker of heart-assist devices posted another quarterly loss and said regulators delayed approval of one of its main projects.

Shares nosedived at the opening bell and fell 17 percent before settling at $17.36 a share, down $2.54, at the closing.

The company said the U.S. Food and Drug Administration returned its submission of approval of its bridge-to-transplant device for heart patients, saying it needed more data from more patients to consider it.

Chief Executive Gary Burbach said he believed the company could submit the needed additional information to the FDA in three months. But until Thoratec does so, consideration of approval of the device will not go forward. Moreover, the company said the delay in FDA consideration of the device is causing it to lower its revenue and earnings forecasts for the year.

Thoratec posted a loss of $275,000, or a penny a share, in the first quarter, on a revenue gain of 18 percent to $57.3from Business 1

million. That is an improvement from a loss of

$930,000, or 2 cents a share, in the year-ago quarter.

Excluding one-time expenses, which included management transitions, litigation and a review of its stock option practices, Thoratec would have earned $4.3 million, or 8 cents a share. Analysts had expected Thoratec to earn 7 cents, according to a poll by Thomson
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