Prior to regulatory approval Tissuemed’s products are subject to a variety of biocompatibility tests. This rigorous scrutiny provides our customers with confidence to use our products safely. The TissuePatch3 product family now incorporating five products, including the recently CE marked TissuePatchDS (a double sided adhesive device) is a multi-laminate synthetic sealant film incorporating polylactide-co-glycolide (PLGA) and Tissuemed’s adhesive polymer, ‘Tissuebond’. PLGA is one of the most common biodegradable polymers used in implantable medical devices and as a consequence there are numerous publications devoted to it’s biocompatibility, corresponding tissue response and ultimate degradation. By virtue of being a novel bioadhesive, the biocompatibility of ‘Tissuebond’ has not been reported.
In the next few weeks Tissuemed will be providing a new Technical Bulletin detailing the fate of TissuePatch3 and associated components. As a preview to this much anticipated document here’s an histology image from a section implanted for a period of 12 weeks. This H&E section, magnified 100 fold, shows the remains of TissuePatch3 with cellular infiltration and a minimal tissue response.