This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: DuraSeal Spine Sealant System
PMA Applicant: Covidien
Address: 101A First Avenue, Waltham, MA 02451
Approval Date: September 4, 2009
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080013a.pdf
What is it? The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. The System consists of components to prepare an absorbable sealant (polyethylene glycol hydrogel) and a delivery system (an applicator and spray tips, packaged in a single use kit). The sealant is composed of two solutions (polyethylene glycol (PEG) ester and trilysine amine) referred to as the blue and clear precursor solutions.
How does it work? When mixed together, the two solutions rapidly combine (in situ polymerization) to form a sealant gel that seals the dura mater. The dura mater is the tough, outermost, fibrous membrane that covers the brain and spinal cord, and lines the inner surface of the skull. The sealant is sprayed or layered onto the sutured incision site. It adheres to the tissue and it is more than 90% water. The blue color helps the surgeon see the sealant, which naturally breaks down and is absorbed within four to eight weeks, enough time to allow for healing.
When is it used? The DuraSeal Dural Sealant System is used as an aid during spinal surgery to prevent cerebrospinal fluid leakage along dural sutures by forming a watertight closure.
What will it accomplish? DuraSeal Spine Sealant has demonstrated to seal 100% of sutured dural incisions as evaluated intra-operatively.
When should it not be used? DuraSeal should not be applied to confined bony structures where nerves are present since neural compression may result due to hydrogel swelling. The hydrogel may swell up to 50% of its size in any dimension.
Additional information: The Summary of Safety and Effectiveness and Labeling are available online.