Gecko Biomedical receives CE Mark Approval for SETALUM ™ Sealant

Paris, France, September 11, 2017 – Gecko Biomedical (“Gecko”), a medical device company developing innovative polymers to support tissue reconstruction, announced today 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 The 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 we t 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.“The SETALUM™ sealant can be precisely and easily applied thanks to its viscosity and hydrophobicity and then activated at will to provide an instant hermetic barrier and effective hemostasis. The key features of this polymer technology were selected with physicians and patients in mind, and sig nificantly improves upon the latest generation of hemostatic agents to ...
Source: Medical Hemostat - Category: Medical Devices Authors: Source Type: blogs