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Boston Sci could resume ICD sales within 30 days

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health care

* Analysts said device maker acted cautiously

* Sales halt resulted from incomplete documentation

* Company has no further comment after halting sales

By Susan Kelly

CHICAGO, March 17 (Reuters) - Boston Scientific Corp.
(BSX.N: Quote, Profile, Research) could be selling implantable heart rhythm devices again
within 30 days if no new issues arise beyond the paperwork
problems revealed this week.

"Our number one conclusion is ... that Boston likely
overreacted in pulling its products from the market and has a
good chance of getting this resolved in the next week or two
with the outside risk being 30 days," JPMorgan analyst Michael
Weinstein wrote in a note to clients.

Boston Scientific spokesman Paul Donovan declined to
provide details on when the company might resume selling the
devices but said, "We are working closely with the FDA to
resolve the situation as soon as possible."

The company said on Monday it was halting all sales of its
implantable cardioverter defibrillators and cardiac
resynchronization therapy devices, stunning investors who sent
its shares tumbling almost 20 percent.

Boston Scientific said it made the decision after
discovering in a review that it had failed to submit required
documents to the U.S. Food and Drug Administration and obtain
necessary approvals for two changes it made to its
manufacturing processes.

Boston Scientific said the defibrillators pose no risk to
patients, and it does not recommend any devices be removed from
patients. The devices, which deliver electrical pulses to help
coordinate heart pumping, represent about 15 percent of the
company's total sales. The action covers seven different brands
of ICDs and CRT-Ds.

Bernstein analyst Derrick Sung said manufacturing process
changes generally require a 30-day review by the FDA. "Given
Boston Scientific's conservative actions, the FDA seems
unlikely to take punitive actions," Sung said.

He predicted Boston Scientific would incur market share
loss of 4 percent due to a one-month sales suspension. The lost
sales would shave 5 cents off the company's 2010 earnings per
share, while adding 4 cents per share to rival Medtronic Inc's
(MDT.N: Quote, Profile, Research) earnings and 6 cents a share to St Jude Medical's
(STJ.N: Quote, Profile, Research).

Weinstein estimated St Jude stands to see a 63 percent
increase in its business and Medtronic Inc a 29 percent boost,
assuming Boston Scientific is off the market for 30 days.

The affected products are the Cognis, Confient, Livian,
Prizm, Renewal, Teligen, and Vitality defibrillator brands.

Boston Scientific acquired the defibrillator business when
it spent $27 billion to buy Guidant Corp in 2006 in a deal
widely criticized for its steep price tag and that left the
company saddled with debt and battling lawsuits and
investigations.

The sales halt was the latest in a series of setbacks for
the medical device maker, which in the past several months has
announced a $1.7 billion stent patent settlement with rival
Johnson & Johnson, a major restructuring and job cuts, and two
deals with the U.S. Department of Justice to resolve
long-running probes stemming from the Guidant acquisition.

Shares of Boston Scientific were down 14 cents, or 2
percent, at $6.95 in afternoon trading on the New York Stock
Exchange.
(Reporting by Susan Kelly; Editing by Steve Orlofsky)

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