DuraSeal Dural Sealant System - P040034
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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: DuraSeal Dural Sealant System
Applicant: Confluent Surgical, Inc.
Address: 101A First Avenue, Waltham, MA 02451
Approval Date: April 7, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040034a.pdf
What is it? The DuraSeal Dural Sealant System is used in dura mater surgery and is applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. 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 DuraSeal Dural Sealant System consists of synthetic absorbable sealant materials and an applicator to apply the sealant to the incision site.
This is the first device specifically designed and studied to seal sutured dura mater incisions.
How does it work? The sealant is composed of two solutions, a polyethylene glycol (PEG) ester solution and a trilysine amine solution. When mixed together, the solutions combine to form the sealant gel. The sealant is absorbed in approximately four to eight weeks, enough time to allow for healing.
When is it used? The DuraSeal Dural Sealant System is used following dura mater surgery. It is intended to aid in preventing CSF leakage along dural sutures by forming a watertight closure.
What will it accomplish? DuraSeal was demonstrated to seal 98% 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 sealant gel swelling. The sealant gel may swell to up to 50% of its size in any dimension.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040034