SINGAPORE, UPPSALA, Sweden and CANTON, Mass., Feb. 5 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(TM) Matrix Surgical Mesh, for use in reinforcement of soft tissues where weakness exists. TIGR(TM) 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(TM) 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(TM) Matrix Surgical Mesh that recently completed enrollment.
"This new technology is exciting as it represents a breakthrough in hernia mesh repair -- TIGR(TM) 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(TM) 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.
About Novus Scientific
Novus Scientific (www.novusscientific.com) is an innovator in the development and commercialization of resorbable synthetic medical devices. Global HQ is in Singapore while European HQ and the core R&D function are in Uppsala, Sweden. The company's roots are Swedish as all the founders of Novus Scientific are previous owners / senior managers / members of the soft tissue-engineering project within Uppsala-based, Radi Medical Systems AB (now owned by St. Jude Medical Inc). Novus also has offices in the US and UK.
TIGR(TM) is a trademark of Novus Scientific Pte. Ltd.
CONTACT: Ben Craven, +46-730-345522, [email protected]
, or James Archetto, +1-781-577-2599, [email protected]
, both of Novus Scientific Pte. Ltd
SOURCE Novus Scientific Pte. Ltd