COSEAL is a completely synthetic sealant for peripheral vascular reconstructions.
Indications
COSEAL is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Features
* Sealing capability within 60 seconds and does not require any human blood products or bovine components to inhibit bleeding 1,3
* Immediate anastomotic sealing [median time to complete sealing 16.5 seconds]1
* No refrigeration required; use directly from shelf [approximately 25°C] to sterile field2
* To suit your needs, COSEAL has four applicator options- including our Hand-Controlled SpraySet system: 7cm and 22cm Flex Direct Tip; Extended Flex Direct Tip for uniform coverage and control
* Flexible, gel-like seal that remains intact at the site of application 3
Safety
* COSEAL is 100% synthetic and avoids risk of patient hypersensitivities to bovine components or glutaraldehyde contributed from the use of a sealant4
Important Risk Information
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 this device, please refer to full device Instructions for Use.
Post time: Aug-21-2017