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| 11/5/2009 1:57:00 PM | Email this article • Print this article | Zimmer Remains Committed To Spine System Despite FDA Setback
Staff Report
A Food and Drug Administration committee voted 5 to 1 against wider use of Zimmer Spines' Dynesys Dynamic Stabilization System Wednesday.
The recommendation came after the FDA raised questions about whether payments to doctors conducting the trials were influencing the results.
Zimmer responded by saying there was no significant treatment-by-compensation interaction found.
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Following Wednesday's decision, Zimmer said in a statement the company "will continue to work with the FDA to determine necessary next steps."
"Zimmer Spine remains committed to the Dynesys system, which has a proven clinical track record over 14 years in more than 42,000 cases globally. The system is used in fusion applications in the United States and non-fusion applications outside of the United States," read a statement released by Zimmer's Director of Public Affairs Brad Bishop. "This recommendation by the FDA panel does not impact use of the product outside of the United States. The company continues to believe the Dynesys system has the potential to become a valuable treatment alternative in a non-fusion application for Americans suffering from lumbar degeneration."
The FDA's advisory panel said Zimmer's data was unclear and raised questions about its durability, according to a Reuters report this morning.
According to the Reuter's report, the system is already approved for use in patients with back problems. Zimmer was seeking permission to market it for stand-alone use.
A final FDA decision will come at a later date.
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