COSEAL Surgical Sealant Indication
COSEAL is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Important Risk Information for COSEAL
- COSEAL is not to be used in place of sutures, staples, or mechanical closure.
- COSEAL swells up to four times its volume within 24 hours of application and additional swelling occurs as the gel resorbs. Therefore, surgeons should consider the maximum swell volume and its possible effect on surrounding anatomic structures potentially sensitive to compression.
- Apply only as a thin layer.
- Use caution when applying with pressurized gas.
- Do not place devices or other objects on top of tissue where COSEAL has been applied, until the material is fully polymerized (non-tacky).
- Do not apply COSEAL over any devices or objects that will need to be removed. COSEAL must not be used as a mechanism of adherence, even temporarily, for any object.
- Do not inject COSEAL into vessels.
- In vivo testing demonstrated a mild skin sensitization response in an animal model. Similar testing in humans has not been conducted.
Rx Only. For safe and proper use of these devices, refer to the appropriate full device Instructions for Use.
Baxter, Coseal and Easyspray are registered trademarks of Baxter International.
Gelfoam is a registered trademark of Pharmacia & UpJohn Company LLC and is used under license.
USBS/185/14-0002(2) July 2016