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Medical Devices / Submissions and Approvals

Gecko Biomedical Receives CE Mark Approval for SETALUM Sealant

Sept. 14, 2017
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Gecko Biomedical received CE Mark approval for its SETALUM Sealant allowing the company to market the technology in Europe.

The bioresorbable sealant can be used as an add-on to sutures during vascular surgery. The polymer is applied to tissue in-situ and activated using a proprietary light activation pen.

The CE Mark is the first regulatory validation of Gecko Biomedical’s polymer platform.

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