FDA Experts Recommend 2nd Neck Disc Approval
An advisory panel to the U.S. Food and Drug Administration has recommended approval of a second artificial neck disc, just days after the full agency approved the first such product.
The expert panel voted 7-1 late Wednesday to recommend full FDA approval of Medtronic's Byran disc. Just two days earlier, the full agency sanctioned the same company's Presitge disc for sale in the United States.
Medtronic says its Byran disc is a newer design and more closely resembles a natural spinal disc than its Prestige model, The New York Times reported.
Damage to the discs in the neck, medically referred to as the cervical spine, often requires a surgical procedure called fusion to relieve neck and arm pain. As many as 250,000 of the procedures are performed each year in the United States, the Times said.
The full FDA isn't bound by the decisions of its expert panels, but usually follows them.
Separately, the FDA posted on its Web site a warning letter sent to Medtronic about reporting and monitoring problems at the firm's Minneapolis plant where implantable pain pumps are made, the Times said. Medtronic issued a statement saying it was working with the agency to resolve the issue.
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Intensive Tennis Training Could Injure Young Players: Study
The intensive training often given to young tennis players could wind up damaging their spines, according to research to be published in the British Journal of Sports Medicine.
Researchers at the UK's Royal National Orthopaedic Hospital took MRI scans of 33 players ages 16 to 23 with no symptoms of pain. They found "a variety of spinal abnormalities in the lower back, some of which were irreparable," the journal said in a prepared statement.
The problems included disc degeneration, herniated discs, and spinal fractures, the journal said.
The study authors recommended modifying training techniques to "minimize the risk of progressive musculoskeletal damage."
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Food Makers Pledge to Limit Ads Aimed at Children
Eleven prominent food and drink companies have agreed to limit U.S. advertising aimed at children under 12, the Associated Press reported Wednesday.
The announcement came just before the start of hearings Wednesday by the Federal Trade Commission into whether the growing child obesity problem could be curtailed by more responsible marketing practices, the wire service said.
The food makers included: Campbell Soup Co., General Mills, PepsiCo, McDonald's, Cadbury Adams, the Coca-Cola Co., The Hershey Co., Unilever, Masterfoods, Kellogg Co., and Kraft Foods, the AP reported.
The self-imposed rules included a pledge by seven of the companies to no longer use characters made popular by television and movies in their ads aimed at children, unless the ads promoted healthier products.
The voluntary commitments also affect advertising in schools and online advertising aimed at youngsters. The rules should be fully implemented by the end of next year, the AP said.
"These companies have taken a laudable step toward promoting healthier products to children and implementing changes in marketing practices that are truly meaningful," Joanne Lupton, President of the American Society for Nutrition, said in a prepared statement. |