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COSEAL [Surgical Sealant] |
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![COSEAL [Surgical Sealant]](/images/products/biopharmaceuticals/coseal.jpg)
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COSEAL is a completely synthetic hemostatic sealing agent for peripheral vascular reconstructions.
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Rx Only: For safe and proper use of this device, please refer to full device Instructions For Use (pdf 252k). |
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COSEAL is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage. |
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- Sealing capability within 60 seconds and does not require any human blood products or bovine components to inhibit bleeding1
- 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: 8cm 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 application3
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- Completely synthetic and glutaraldehyde free4
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| Important Safety Information |
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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.
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- Glickman M., Gheissari A., Money S, Martin J., & Ballard J.L. A polymeric sealant inhibits anastomotic suture hole bleeding more rapidly than gelfoam/thrombin. Arch Surg. Vol 137:March (2002):326-331.
- COSEAL Surgical Sealant Instructions for Use, 03/2006.
- Hill A., Estridge T.D., Maroney M., Monnet E., Egbert B., Cruise G., & Coker G.T. Treatment of suture line bleeding with a novel synthetic surgical sealant in a canine iliac PTFE graft model. January (2001) 308-312.
- Materials Data Safety Sheet, Baxter Healthcare Corporation.
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COSEAL is a trademark of Angiodevice International GmbH. |
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