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COSEAL [Surgical Sealant]

COSEAL [Surgical Sealant] is a completely synthetic sealing agent for vascular reconstruction.

Prescribing Information

For full prescribing information, please view the package insert (pdf 252k).

Indications

COSEAL [Surgical Sealant] is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

How It Works

  • Prep time can be as short as 1 minute1
  • Seals almost immediately1
  • Room temperature storage up to 25° C
  • No thawing, heating or light activation required
  • Easy to handle applicator
  • Quick polymerization ensures that COSEAL [Surgical Sealant] stays where it is applied
  • Flexible, gel-like seal that remains intact at the site of application
  • Strong enough to withstand the stress of arterial pressure2
  • Applicator tips allow easy access to challenging anatomy
Safety and Efficacy

  • Absolutely no human or animal proteins; therefore, no risk of viral transmission
  • Latex free
  • Completely resorbed within 30 days of application3
  • Interaction with clotting cascade not required
  • Quickly forms an elastic, watertight seal between itself and the tissue surface to prevent fluid leaks
  • Effective on heparinized patients
Important Safety Information

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.

References

  1. COSEAL [Surgical Sealant] Instructions for Use
  2. Validation Report: VAL219.
  3. Technical reports: TS-98-001, TS-98-002.


  4. COSEAL is a trademark of Angiodevice International GmbH.
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