Covidien's DuraSeal spine sealant wins FDA nod

September 8, 2009 by MassDevice staff

Covidien's DuraSeal surgical sealant landed approval from the Food & Drug administration for use during spinal procedures and should hit the market in the next few weeks.

The Mansfield, Mass.-based devices giant said it's the first product approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.

The product is designed to quickly seal dural leaks, according to Covidien, which claims it takes only two minutes to prepare and three seconds to set.

It was approved in 2005 for use during cranial procedures; since then the copmapny syas it's sold more than 210,000 units.

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