St. Jude Down on FDA Delay

The medical device maker still expects approval of its new ICD product.
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St. Jude Medical

(STJ)

has experienced a temporary setback for launching a new generation of devices to treat erratic heartbeats, which knocked down its stock $1.52, or 2%, to $73.22 Monday.

The St. Paul, Minn.-based medical device company said Friday afternoon, after markets had closed, that it won't get regulatory approval as quickly as it had expected. The company had hoped that the Food and Drug Administration would grant approval later this week for the device known as an implantable cardioverter defibrillator (ICD). The device delivers an electrical charge to treat dangerously fast heart rates.

The FDA "has not advised St. Jude Medical of any substantive concerns" with the company's application for the device, the company said Friday.

St. Jude Medical added that it still expects to get FDA approval during the second quarter and also expects to begin marketing the new ICD in July.

The company said the delay should not affect its guidance for second-quarter earnings in the range of 52 cents to 54 cents per share or the full-year EPS guidance of $2.13 to $2.18.

The only impact so far will be a slight trimming of ICD sales for the second quarter to $120 million from $125 million, assuming that there are no other delays. The company expects full-year ICD sales to be in the range of $550 million to $580 million.

St. Jude Medical sold $119.6 million worth of ICDs for the three months ended March 31, or 22% of corporate sales.