Omrix Biopharmaceuticals has announced that the FDA has approved its bleeding control product for use during liver surgery.
Omrix said the FDA approved its Evicel fibrin sealant to control bleeding during liver surgery. However, the company said it also submitted data to the agency on using the product during peripheral vascular surgery to expand the product's approval.
To get FDA approval for general surgery, the company must provide data using the product in one more type of surgery. Omrix said it is working on a clinical trial using Evicel during kidney surgery.