Novus Scientific has presented the initial results of the First-in-Man study for TIGR Matrix Surgical Mesh, at the American Hernia Society Meeting in Orlando, Florida. The results were presented by Dr Fernando Ruiz-Jasbon, consultant surgeon at Kungsbacka Hospital/Gothenburg University, Sweden.
The company said that in the study, 40 patients with primary inguinal hernias were enrolled and TIGR Matrix was implanted for hernia repair. Clinical outcome is being assessed at 0.5, 1, 3, 6 and 12 months. In preliminary follow-up, there have been no serious adverse events and the mean pain score assessed when coughing fell from 17.4 prior to surgery to 0.3 at 6 months.
TIGR Matrix Surgical Mesh is the long-term resorbable, synthetic matrix. It is knitted from two different resorbable fibers that degrade at different rates following implantation. The patented dual-fiber design provides an initial high strength / high stability configuration, with gradually increasing compliance over time as the product is resorbed. TIGR Matrix Surgical Mesh is 100% synthetic and macroporous. On January 25th, 2010, the FDA has granted 510(k) clearance for TIGR Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists.
Thomas Engstrom, CEO and president of Novus Scientific, said: “We are satisfied with the positive reaction of surgeons to this study using TIGR Matrix. The level of interest shown during the Orlando meeting has further reinforced our belief that a long-term resorbable mesh is the future of soft tissue repair. Based on the responses of the surgeons and the positive data from this study, we are currently planning further studies.”
Dr Ruiz-Jasbon, said: “Handling this product during the procedure is no different to a standard mesh. However, I envision that the long-term resorbable characteristics of the product will be a successful new concept for treating hernia patients. These patients will continue to be followed long-term as part of the Swedish National Hernia Registry. This will allow us to assess the long-term safety of TIGR Matrix and also see if there is a difference in long-term complications compared with the standard implantation of permanent foreign materials.”