Image: The blood-resistant surgical glue seals vasculature (Photo courtesy of Gecko Biomedical).
A new surgical glue is based on a proprietary polymer that demonstrates superior biocompatibility, tunable bioresorbability and adjustable tissue adherence.
The Gecko Biomedical (Paris, France) SETALUM Sealant is a hydrophobic light-activated adhesive (HLAA) designed for both wet and dynamic environments as an add-on to sutures during minimally invasive vascular surgery. Unique chemical and physical properties include high viscosity, hydrophobicity, and on demand curing. The adhesive, which is based on a mixture of easily metabolized glycerol and sebacic acid, can be brushed on a biological surface and set in seconds with a short application of ultraviolet (UV) light.
Unlike other sealants that work through a chemical reaction, SETALUM works by a physical mechanism, becoming physically entangled with collagen and other tissue surface proteins, following activation with a proprietary UV activation pen. In the European CE Mark clinical study, conducted in four hospitals in France, in patients undergoing carotid endarterectomy, 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.
“We are delighted to receive the CE Mark for our first product, SETALUM sealant, as this will allow us to bring new and innovative solutions to the market to improve patient care,” said Christophe Bancel, CEO of Gecko Biomedocal. “Our ability to bring an entire new family of innovative polymers from the bench to the bedside in less than two and a half years is a testimony of the versatility and scalability of our 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,” said vascular surgeon Jean-Marc Alsac, MD, PhD, principal investigator of Gecko Biomedical’s BlueSeal clinical study. “Key features of this polymer technology were selected with physicians and patients in mind, and significantly improve upon the latest generation of hemostatic agents to become a gold standard in vascular surgery.”