Ireland-based healthcare products maker Covidien plc (COV) has won approval of the U.S. Food and Drug Administration’s (“FDA”) for its DuraSeal Exact sealant for use in spine procedures. The company plans to launch the product shortly.
Roughly 1.5 million spine surgeries are performed in the U.S. annually with around 10% of these procedures requiring dural repair and sealing. Dura (or dura mater), is the outermost and toughest of the three layers of membranes surrounding the brain and the spinal cord. It is responsible for protecting the cerebral spinal fluid. Tears in the dura may result in leakage in cerebral spinal fluid following surgery, leading to potential medical complications and extended hospital stays.
The DuraSeal Exact spine sealant has been designed as an adjunct to suturing to repair the dura. The launch of the product will follow Covidien’s 2009 launch of its DuraSeal Spine sealant in the U.S., the first FDA-approved product for intra-operative sealing of the dural membrane during spine procedures. DuraSeal sealants are currently marketed in Europe and other international markets.
DuraSeal Exact is a 100% synthetic absorbable hydrogel that provides tissue adherence, safe absorption and a consistent watertight seal around the dura. It is formulated with lower molecular weight than the DuraSeal Spine sealant, which allows reduced post-application swelling.
DuraSeal Exact has been designed as a quicker solution than the legacy sealing methods. It takes just a couple of minutes to prepare and three seconds or less to set, allowing surgeons to complete an intra-operative dural seal quickly.
Covidien is a leading global healthcare products company that develops and markets medical solutions for better patient outcomes. The company’s core medical devices business faces stiff competition from Johnson & Johnson (JNJ), Becton Dickinson (BDX) and C.R. Bard (BCR).
Covidien boasts a well diversified product and technology portfolio. The company remains committed to rolling out new products and technologies, focusing on faster-growing products and markets, and boosting market share in core segments through investments in sales and marketing infrastructure. The approval of DuraSeal Exact underscores Covidien’s commitment to providing surgeons a product to enhance dural sealing during spine surgeries.
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