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 statement coming…
Reuters… http://ow.ly/zlyB
WSJournal…. http://ow.ly/zlAt