Novus Scientific Pte. Ltd today announced that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the TIGR™ Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists. TIGR™ Matrix Surgical Mesh is a 100 percent resorbable, synthetic matrix, knitted from two different resorbable fibers that degrade at different rates following implantation. This unique patented dual-fibre design provides an initial high strength / high stability configuration, with gradually increasing compliance over time as the product is resorbed. The macroporous structure is designed to allow tissue integration for reliable tissue repair.
TIGR™ Matrix Surgical Mesh is the world's first long-term resorbable, synthetic matrix, with dual stage mechanics, which is a significant new addition to the surgeon's toolbox.
"This technology is a new treatment option, which fills a gap in the market for ventral, incisional and inguinal hernia patients, and may avoid the potential long-term complications of permanent synthetic meshes," said Bruce Ramshaw, MD.
"It is very desirable to avoid leaving permanent foreign materials in the body. This provides us with a new tool to repair abdominal wall defects in a very logical way," said A/Prof. Stellan Bjorck of Sahlgrenska University Hospital, Gothenburg, Sweden. A/Prof. Bjorck is the Principle Investigator for the first clinical study of the TIGR™ Matrix Surgical Mesh that recently completed enrollment.
"This new technology is exciting as it represents a breakthrough in hernia mesh repair -- TIGR™ Matrix Surgical Mesh is a new synthetic mesh that is 100% resorbable. From early clinical experience, it may provide a new therapeutic option for inguinal hernia and in the future for ventral and incisional hernia repair," said A/Prof. Davide Lomanto, President of the Asia-Pacific Hernia Society and Senior Consultant at National University Hospital, Singapore.
"We are very excited to be able to introduce the TIGR™ Matrix Surgical Mesh to US surgeons, as the first in a line of state-of-the-art synthetic resorbable medical devices," said Thomas Engstrom, CEO & President of Novus.
SOURCE Novus Scientific Pte. Ltd