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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 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.
“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 significantly improves upon the latest generation of hemostatic agents to become a gold standard in vascular surgery,” said Jean-Marc Alsac, MD, PhD, vascular surgeon at the Hôpital Européen Georges Pompidou in Paris, France and the principal investigator of Gecko Biomedical’s BlueSeal clinical study.
Read the press release here: http://www.businesswire.com/news/home/20170911005044/en/Gecko-Biomedical-receives-CE-Mark-Approval-SETALUM%E2%84%A2
For Further Information
More on the wound tissue market in Europe can be found in a series of reports published by iData Research entitled the Europe Market Report Suite for Wound and Tissue Management. The suite covers reports on the following markets: Wound Closure, Static Compression Therapy, Dynamic Compression Therapy, Advanced Dressings, Moist Dressings, Antimicrobial Dressings, Interactive Dressings, Non-Adherent Contact Layers, Traditional Wound Dressings, Hemostats, Tissue Sealants, Anti-Adhesion, and Negative Pressure Wound Therapy.
The iData report series on wound and tissue management covers the U.S., Japan, India, China and 15 countries in Europe including Austria, Belgium, Denmark, Finland, France, Germany, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom, and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about wound tissue management market data, register online or email us at [email protected] for a Europe Market Report Suite for Wound and Tissue Management brochure and synopsis.