The FDA Neurological Devices Panel said that Duraseal should be approved to prevent spinal fluid leakage during surgery. The product is already approved for use during brain surgery, according to the report.
FDA’s advisers attached several conditions to their endorsement, including a postmarket study to track safety issues for up to 90 days after surgery and said that the product’s labeling should mention that the long-term leakage rate for the device was about the same as surgical stitches, the current standard treatment, according to the repot.
Read about the FDA panel’s recommendation for Duraseal.
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