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Feb 8


Boston Scientific Drops on Reported Halt of ICD Sales
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Boston Scientific Corp. fell 15 percent in early trading after analysts said the company had halted sales of heart-rhythm devices because of a documentation error with its U.S. regulatory filings.

Boston Scientific is “indefinitely suspending” sales of implantable cardioverter defibrillators, or ICDs, until the Food and Drug Administration reviews a change in manufacturing that would otherwise make the company noncompliant with federal law, said Derrick Sung, an analyst at Sanford Bernstein & Co. in New York, today in a note to clients.

The devices brought in $1.79 billion last year, or 22 percent of Boston Scientific’s revenue, according to data compiled by Bloomberg. Suspending sales and implants of these products will probably benefit market leader Medtronic Inc. and smaller competitor St Jude Medical Inc., Sung said.

“At this point, we don’t know if the suspension will be days, weeks, or months,” Sung said. It “could have a significant negative impact to Boston Scientific’s business both from an acute and longer term perspective.”

The Natick, Massachusetts-based company declined $1.38, or 18 percent, to $6.40 at 8:52 a.m. in trading before the New York Stock Exchange opened. St. Jude, of St. Paul, Minnesota, gained 7.8 percent and Minneapolis-based Medtronic rose 3.2 percent.

Paul Donovan, a spokesman for Boston Scientific, and Peper Long, a spokeswoman for the FDA, didn’t immediately return e-mail and voice-mail requests for comment.

Last Night

Boston Scientific notified its sales representatives last night about the hold on ICD sales, according to Michael Weinstein, an analyst at J.P. Morgan in New York.

“We don’t see the present FDA issue as permanent, but another hit to a company already reeling from its own self- inflicted wounds and the struggles of share loss and diminished research and development productivity across its businesses,” Weinstein said in a note to clients today.

ICDs are stopwatch-sized devices that are surgically implanted to monitor the heart and deliver electrical shocks when needed to maintain a normal rhythm. Medtronic reported $2.96 billion in revenue from all defibrillation systems in the fiscal year ended April 24. St. Jude reported ICD sales of $1.58 billion in the year ended Jan. 2.

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