COSEAL is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
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 should not be used as a mechanism of adherence, even temporarily, for any object. Do not inject COSEAL into vessels.
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 may occur as the gel resorbs. Therefore, surgeons should consider the maximum swell volume and its possible effect on surrounding anatomic structures potentially sensitive to compression.
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 this device, please refer to full device Instructions For Use.
COSEAL is a registered trademark of Angiodevice International GmbH, used under license.