Gecko Gets EU Nod For Bio-Inspired Surgical Glue, Setalum
Paris-based Gecko Biomedical, a medical device company developing innovative polymers to support tissue reconstruction, announced today that it has received CE Mark approval for its Setalum sealant.
The firm said Setalum is a biocompatible, bioresorbable sealant designed as an add-on to sutures, and is usable in wet and dynamic environments and activated using a light activation pen. The CE Mark approval marks the 1st regulatory win for Gecko Biomedical’s Setalum, the company said.
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 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 BlueSeal clinical study was a prospective, single-arm and multi-center clinical investigation performed at four French university hospitals and undertaken in patients necessitating a carotid endarterectomy. Performance of the sealant was evaluated by the percentage of immediate hemostasis following clamp removal. Based on a sequential Bayesian design, the recruitment was stopped at 22 enrolled patients given the fulfilled performance criteria and the optimal safety profile of the sealant. Immediate
hemostasis was achieved in 85% of patients and all recorded adverse events were found to be representative of those commonly occurring in patients necessitating vascular reconstruction with none considered as related to the sealant.“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,” BlueSeal clinical study principal investigator Dr. Jean-Marc Alsac of Paris’ the Hôpital Européen Georges Pompidou said in a prepared statement.
“We are delighted to receive the CE Mark for our 1st product, Setalum sealant, as this will allow us to bring new and innovative solutions to the market to improve patient care. As a result, we are now ramping up our manufacturing capabilities and selection of strategic partners to bring this innovation to patients. Our ability to bring an entire new family of innovative polymers from the bench to the bedside in less than 2 and a half years, is a testimony of the versatility and scalability of our platform. We are now ready to fully expand, internally and through partnerships, into new therapeutic areas to design disruptive, surgical solutions for patients,” Gecko CEO Christophe Bancel said.
