An FDA advisory panel voted 4 to 0 in favor of approving Covidien’s Duraseal sealant for use in spinal surgery. The synthetic polymer sealant, which is sprayed onto the surgical site to create a water-tight seal, is currently approved for use only in cranial surgery.
Panelists said existing data was sufficient to allow the sealant to be used in spine surgery as an alternative to stiches, soft tissue patches or glues for the prevention of fluid leakage. However, the panel recommends that the FDA require Covidien to conduct further studies on the sealant for at least 3 months after it is approved to determine its long-term efficacy.
The FDA will now weigh the panel’s advice before issuing a final decision.
—Irene Tsikitas
