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GAITHERSBURG, Md., Nov 4 (Reuters) - A U.S. panel of medical experts on Wednesday recommended against wider use of a Zimmer Holdings Inc spine stabilization device, questioning the company's data but adding that the device holds promise. The Food and Drug Administration's advisory panel, in a 5-1 vote, said the company's Dynesys Spinal System data were unclear and that some changes should have been made to its clinical trial. They also questioned how the device would hold up over time and expressed concern about possible breakage. Zimmer's device, a series of screws and flexible spacers that aim to help align and support the spine, is already approved for use in patients with back problems who undergo surgical fusion. The company is seeking the agency's permission to market Dynesys for stand-alone use. The company, which also sells another similar spinal device called Silhouette, has said the Dynesys device can allow a greater range of motion for patients than other products. FDA officials will weigh the panel's recommendation before later making a final approval decision. Zimmer shares closed up 1.37 percent at $53.15 on the New York Stock Exchange. (Editing by Carol Bishopric) Keywords: ZIMMER SPINE/ (sheavey@thomsonreuters.com; +1 202-354-5848; Reuters Messaging: susan.heavey.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. 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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