Bloomberg News

Thoratec Rises as Rival Fails to Get FDA Hearing in 2011

October 13, 2011

(Updates with closing stock price in second paragraph.)

Oct. 13 (Bloomberg) -- Thoratec Corp., maker of the only U.S. approved implantable heart pump, rose the most in six months after rival HeartWare International Inc. failed to get a slot in the final regulatory advisory panel hearing for 2011.

Thoratec rose 6.6 percent to $36.13 after the U.S. Food and Drug Administration said next month’s hearing will review devices from Minneapolis-based Medtronic Inc. and Atlanta-based CardioMems Inc. that don’t compete with Thoratec’s heart pump. HeartWare fell 3.5 percent to $62.04.

The possibility that Framingham, Massachusetts-based HeartWare will gain a panel review this year is gone, Thomas Gunderson, an analyst at Piper Jaffray in Minneapolis, said today in a telephone interview. Thoratec, based in Pleasanton, California, has the market to itself in the U.S., while HeartWare’s device is available in Europe and has about half of the German market, Gunderson said.

“It’s a zero-sum game,” he said. “This means HeartWare can’t get onto a panel until 2012, and their entry into the U.S. is delayed a little bit. Every time they are delayed, that means Thoratec gets a little longer time of almost near-exclusive use in the U.S.”

Thoratec makes the HeartMate ventricular assist devices, designed to help shoulder the workload for a failing heart. A study released at the American Heart Association meeting a year ago in Chicago found patients getting HeartWare’s 5-ounce pump had a 92 percent survival rate after six months, compared with an average of 90 percent survival in a national registry of patients who mostly received Thoratec’s HeartMate II.

--Editors: Bruce Rule, Andrew Pollack

To contact the reporters on this story: Michelle Fay Cortez in Minneapolis at

To contact the editor responsible for this story: Reg Gale at

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