CE Mark granted for SETALUM sealant, a bio-inspired surgical glue.- Gecko Medical.

Gecko Biomedical a medical device company developing innovative polymers to support tissue reconstruction, announced that it has received CE Mark approval for its SETALUM Sealant allowing the company to market its technology in Europe.

The SETALUM Sealant is a biocompatible, bioresorbable and on-demand activated sealant usable in wet and dynamic environments 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 technology at the foundation of the SETALUM Sealant was developed at he Massachusetts Institute of Technology, Harvard Medical School, and Brigham and Women’s Hospital. SETALUM™ Sealant is the most recent successful example of bio-inspired technology in medicine, and is based on the adhesive mechanisms found in nature that work in wet and dynamic environments. The grant of the CE Mark for the vascular sealant is the first regulatory validation of the safety and performance of Gecko Biomedical’s scalable and innovative polymer platform.