Reuters: Regulatory News: UPDATE 1-FDA staff doubt Cameron device better than rivals

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UPDATE 1-FDA staff doubt Cameron device better than rivals Apr 23rd 2012, 15:00 Tweet Share this Email Print Related Topics Stocks » Regulatory News » Markets » Healthcare » Mon Apr 23, 2012 11:00am EDT WASHINGTON, April 23 (Reuters) - U.S. medical device reviewers said Cameron Health Inc's defibrillator implanted under the skin may have more infection issues, and work less quickly, than similar devices implanted in the heart. The reviewers from the U.S. Food and Drug Administration also said they would not approve Cameron Health's defibrillator, which treats a dangerously irregular heartbeat, until the company resolved issues with a battery that depletes earlier than it should. But the FDA staff said the device, which was implanted in 314 patients, met the company's main goals for safety and effectiveness during clinical trials. The device has been sold outside the United States since July 2009. Boston Scientific Corp agreed to buy privately-held Cameron Health Inc in March. Its shares fell 1.7 percent to $5.84 in morning trading on the New York Stock Exchange. The FDA staff review, posted online on Monday, comes ahead of an advisory panel of outside experts that will vote on the device on Thursday. Cameron Health's defibrillator should be able to give about 21 shocks over its five-year life, but the FDA staff said there have been three cases of premature battery depletion since June 2011, when the company announced the issue. The FDA staff said they would not ask panelists to discuss the battery depletion issue. Like similar devices, Cameron Health's defibrillator delivers electric shocks to help a fluttering heart beat normally. But its electrodes are threaded under the skin along the breastbone, rather than in the heart. In-heart electrodes are known as trasvenous leads. Related Quotes and News Company Price Related News Tweet this Link this Share this Digg this Email Reprints We welcome comments that advance the story through relevant opinion, anecdotes, links and data. If you see a comment that you believe is irrelevant or inappropriate, you can flag it to our editors by using the report abuse links. Views expressed in the comments do not represent those of Reuters. For more information on our comment policy, see http://blogs.reuters.com/fulldisclosure/2010/09/27/toward-a-more-thoughtful-conversation-on-stories/ Comments (0) Be the first to comment on reuters.com. Add yours using the box above.

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