The U.S. Food and Drug Administration has approved Covidien plc’s DuraSeal Exact, a spine sealant designed as an improved version of the company’s already approved DuraSeal.
DuraSeal Exact makes a watertight seal around the dura surrounding the spinal cord, preventing any cerebrospinal fluid leaks, Covidien officials said in a news release Wednesday. The sealant, which the company plans to launch this quarter, is a synthetic absorbable hydrogel that takes two minutes to prepare and three seconds to set.
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