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: Ethicon OMNEX™ Surgical Sealant
Manufacturer: Ethicon, Inc, a Johnson and Johnson Company.
Address: Route 22 West, Somerville, NJ 08876
Approval Date: June 3, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060029a.pdf
What is it? Ethicon™ OMNEX™ is a medical sealant that is used to help stop leaks in blood vessels. It is made of two synthetic components called cyanoacrylate monomers, and does not include any human or animal materials.
How does it work? The two components are mixed together and applied during surgery to form a strong flexible film that seals gaps and holes in the patient’s blood vessels or grafts.
When is it used? Ethicon™ OMNEX™ is used to help seal leaks around sutures in natural or artificial blood vessels.
What will it accomplish? In a clinical research study, immediately after treatment, leaking suture areas were successfully sealed in 55% patients treated with Ethicon™ OMNEX™, as compared to only 10% of patients who received another kind of treatment to stop bleeding. After 10 minutes, leaking suture areas were successfully sealed in 93% of patients treated with Ethicon™ OMNEX™, as compared to 42% of patients who received another kind of treatment to stop bleeding.
When should it not be used? Ethicon™ OMNEX™ should not be used:
- in patients allergic to cyanoacrylate or formaldehyde
- inside blood vessels
- as a replacement for sutures or staples
The safety and performance of Ethicon™ OMNEX™ have not been determined in children and pregnant women or when used in quantities greater than 1000 microliters per patient.
- Summary of Safety and Effectiveness and labeling are available online.