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: CoSeal™ Surgical Sealant
Manufacturer: Baxter Healthcare Corporation.
Address: 34175 Ardenwood, Freemont, California 94303, USA
Approval Date: December 12, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030039a.pdf
What is it? CoSeal™ is a surgical sealant that is used to help stop leaks in blood vessels. It is made of two chemicals called Polyethylene Glycols (PEGs).
How does it work? The two PEGs are mixed together as they are applied during surgery to form a glue-like product which seals the area. CoSeal™ fills gaps and plugs holes on the patient’s blood vessels or on plastic artificial arteries.
When is it used? CoSeal™ is used to seal leaks around sutures (surgical stitches), staples or other mechanical closure devices in natural or artificial blood vessels.
What will it accomplish? In a research study, CoSeal™ successfully sealed leaking suture areas within 10 minutes of application in 81% of patients, compared to 78% of patients who did not receive CoSeal™. Side effects of CoSeal™ could include:
- failure of CoSeal™ to seal gaps and holes,
- application of CoSeal™ to a non-intended area,
- an inflammatory, immune or allergic reaction,
- hemorrhaging (bleeding), or
When should it not be used? CoSeal™ should not be used:
- in pregnant women,
- in children,
- inside blood vessels,
- as a replacement for sutures, staples or mechanical closure devices, or
- in quantities greater than 16 milliliters per patient.
- Summary of Safety and Effectiveness and labeling is available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p030039