By Susan Kelly
CHICAGO, March 29 (Reuters) - Boston Scientific Corp , which pulled its implantable heart defibrillators from the U.S. market two weeks ago, indicated on Monday that it could be another two weeks before it could begin selling them again.
The company on March 15 said it was halting sales of seven brands of implantable cardioverter defibrillators and cardiac resynchronization devices after failing to submit the necessary documents to U.S. regulators to get approval for two changes it made to its manufacturing processes.
The devices, which are implanted in the chest and deliver electrical pulses to help coordinate heart pumping, represent about 15 percent of the company's sales.
The recall stunned investors, who sent the company's shares tumbling 20 percent.
Boston Scientific said on Monday it made the submissions to the U.S. Food and Drug Administration on March 15 and 16 and expects a decision within 30 days of the agency's receipt of the paperwork, according to a transcript of a conference call with physicians contained in a company filing with the U.S. Securities and Exchange Commission.
The FDA would not expedite the review process, Boston Scientific said. 'It appears we will have to wait our turn in the queue,' said Boston Scientific Chief Executive Ray Elliott.
The company reiterated that the manufacturing changes posed no risk to patient safety, and was not recommending that patients have implanted devices removed.
It elaborated on the nature of the manufacturing changes, which it said met its own quality system requirements. In one case, it did not submit data for a subcomponent provided by a supply vendor.
In the second case, the company said it failed to file the required documentation on a change to the cleaning process for its defibrillator manufacturing line that occurred when it standardized cycle times with its pacemaker line.
Boston Scientific sought to allay physician concerns about its plans to return to the market.
'You should feel confident that Boston Scientific is on solid ground financially. We will weather this storm and will be here to support you and your patients for the long term,' Hank Kucheman, the head of Boston Scientific's cardiology business, told physicians on the call.
The recall was the latest in a series of setbacks for the medical device maker, which in recent 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. Justice Department to resolve long-running probes stemming from the 2006 acquisition of Guidant Corp.
Bernstein analyst Derrick Sung estimated Boston Scientific is losing 3 cents of earnings per share for every month that its ICDs stay off the market, as well as three to five points of market share.
Boston Scientific stock rose 5 cents at $7.06 in midday trading on the New York Stock Exchange.
(Reporting by Susan Kelly. Editing by Robert MacMillan and Gerald E. McCormick) Keywords: BOSTONSCIENTIFIC/ (susan.kelly@thomsonreuters.com; phone 312 408 8134; Reuters Messaging: susan.kelly.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
CHICAGO, March 29 (Reuters) - Boston Scientific Corp , which pulled its implantable heart defibrillators from the U.S. market two weeks ago, indicated on Monday that it could be another two weeks before it could begin selling them again.
The company on March 15 said it was halting sales of seven brands of implantable cardioverter defibrillators and cardiac resynchronization devices after failing to submit the necessary documents to U.S. regulators to get approval for two changes it made to its manufacturing processes.
The devices, which are implanted in the chest and deliver electrical pulses to help coordinate heart pumping, represent about 15 percent of the company's sales.
The recall stunned investors, who sent the company's shares tumbling 20 percent.
Boston Scientific said on Monday it made the submissions to the U.S. Food and Drug Administration on March 15 and 16 and expects a decision within 30 days of the agency's receipt of the paperwork, according to a transcript of a conference call with physicians contained in a company filing with the U.S. Securities and Exchange Commission.
The FDA would not expedite the review process, Boston Scientific said. 'It appears we will have to wait our turn in the queue,' said Boston Scientific Chief Executive Ray Elliott.
The company reiterated that the manufacturing changes posed no risk to patient safety, and was not recommending that patients have implanted devices removed.
It elaborated on the nature of the manufacturing changes, which it said met its own quality system requirements. In one case, it did not submit data for a subcomponent provided by a supply vendor.
In the second case, the company said it failed to file the required documentation on a change to the cleaning process for its defibrillator manufacturing line that occurred when it standardized cycle times with its pacemaker line.
Boston Scientific sought to allay physician concerns about its plans to return to the market.
'You should feel confident that Boston Scientific is on solid ground financially. We will weather this storm and will be here to support you and your patients for the long term,' Hank Kucheman, the head of Boston Scientific's cardiology business, told physicians on the call.
The recall was the latest in a series of setbacks for the medical device maker, which in recent 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. Justice Department to resolve long-running probes stemming from the 2006 acquisition of Guidant Corp.
Bernstein analyst Derrick Sung estimated Boston Scientific is losing 3 cents of earnings per share for every month that its ICDs stay off the market, as well as three to five points of market share.
Boston Scientific stock rose 5 cents at $7.06 in midday trading on the New York Stock Exchange.
(Reporting by Susan Kelly. Editing by Robert MacMillan and Gerald E. McCormick) Keywords: BOSTONSCIENTIFIC/ (susan.kelly@thomsonreuters.com; phone 312 408 8134; Reuters Messaging: susan.kelly.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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