Orthopedic company Zimmer Holdings Inc. is currently seeking FDA approval for its titanium Dynesys implant, which restabilizes the spine. The implant appears to be effective for treating certain spinal problems, but FDA is also trying to determine is whether trial data for the device was tainted by Zimmer’s payments to doctors. The agency is holding a panel meeting today to discuss the device. (Read FDA’s executive summary for the panel here.)
Most of the trial participants for the Dynesys were treated by surgeons who were paid consultants for Zimmer. FDA’s review says that the majority of the patients were treated at medical centers that took in more than $100,000 in payments from the company. And one analysis shows a positive relationship between clinical success and financial payments, according to FDA’s review.
However, FDA said that “all correlations were far from being statistically significant.”
