Guidant Gets U.S. Approval to Relaunch Heart Failure Device
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CHICAGO — Guidant Corp. said Monday that it had received U.S. approval to relaunch its top-selling implantable heart failure devices after a recall and that sales would resume as early as midweek.
The approval by the Food and Drug Administration for the Contak Renewal 3 device in the United States means Guidant soon will have a complete product line on the market again. This should help dispel lingering doubts that its deal to be acquired by Johnson & Johnson for $25.4 billion is in peril, analysts said.
The medical device maker in June had stopped its Contak Renewal 3 failure product from use in implants and halted distribution after it was found to have defects in a switch component.
The product, sold as Contak Renewal 4 in Europe, received clearance there last week for a relaunch.
The relaunch improves the odds that Johnson & Johnson’s takeover will be completed by the third quarter, as originally planned, at the agreed-upon price of $76 a share, analysts said.
Guidant said it expected to resume worldwide distribution and implants of the devices by midweek, and have a full supply of the products this month.
Shares of Indianapolis-based Guidant rose $2.52, or 3.7%, to $71.32.
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