Covidien Introduces First FDA-Approved Spine Sealant

At this year’s NASS annual meeting, Covidien launched its DuraSeal spine sealant, which the company said it is the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane—the outermost membrane covering the brain and spinal cord—during spine procedures.

Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10 percent of these surgeries requiring dural repair and sealing. Tears in the dura can result in cerebral spinal fluid (CSF) leaks after surgery, leading to possible medical complications and extended hospital stays.

According to a study released this year by the Congress of NeuroSurgeons, CSF leaks after spinal surgery are estimated to cost an average of $6,479 in additional expense, mainly due to longer hospital and intensive care unit stays

In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100 percent of the time, compared with 64 percent of the time by the control group, according to Covidien. The safety results between the two groups were similar, given the patients’ medical conditions and the nature of the complex spinal procedures performed.

The new sealant is a 100 percent synthetic hydrogel that provides tissue adherence and is absorbed by the body.