Guidant ( GDT ) said Wednesday that it had received Food and Drug Administration approval for its Vitality 2 implantable cardioverter defibrillator system.

The Vitality 2 is the company's latest version of its existing device designed to treat patients at risk for sudden cardiac death as a result of an irregular heartbeat. The company said a full market launch is scheduled for May.

The Indianapolis medical device maker said sudden cardiac death claims the lives of as many as 460,000 people a year in the U.S. alone.

Guidant previewed first-quarter earnings on Tuesday, saying revenue would reach $934 million, slightly above the consensus estimate of analysts polled by Thomson One Analytics. In addition, the company guided in line with the Wall Street consensus EPS of 55 cents.

The company reports official quarterly results April 22.

Shares fell 88 cents, or 1.3%, to $67.26.

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