Campbell P K. Et al. Table: ISO tests required for surgical sealants and list of tests carried out. Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. Integra reserves the right, without prior notice, to modify the products in order to improve their quality. Please contact Integra customer service should you need any additional information on devices classification.
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Your choice of sealant matters. With demonstrated superior tissue adherence versus fibrin glue, DuraSeal Exact is engineered for appropriate strength and optimal duration for the tighter confines and higher pressures of the spine. DuraSeal Exact is indicated as an adjunct to sutured dural repair during spine surgery to provide watertight closure. It is a polymer composed of two solutions, a polyethylene glycol PEG ester solution and a trilysine amine solution.
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UPDATE 1-Covidien DuraSeal product gets FDA approval
DuraSeal Exact spine sealant is a new, low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The dura mater, or dura, encompasses the three layers of the meninges surrounding the spinal cord that protect and hold cerebrospinal fluid. Wright, M. DuraSeal Exact spine sealant is formulated with a lower molecular weight than its predecessor, resulting in decreased post-application swelling and allowing surgeons to confidently use the product in spinal surgery. DuraSeal dural sealant was approved by the FDA in for use during brain surgery. DuraSeal sealants are also available in Europe and other international markets. Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.
Covidien DuraSeal Exact Gets U.S. Green Light