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FDA Clears Novus’ TIGR Matrix Surgical Mesh

Novus Scientific (Novus) has received FDA 510(k) clearance to market the 'TIGR Matrix' surgical mesh, for use in reinforcement of soft tissues where weakness exists. TIGR Matrix is a 100% resorbable, synthetic matrix, knitted from two different resorbable fibers that degrade at different rates following implantation.

The company said that the patented dual-fibre design of TIGR Matrix 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. This surgical mesh is the long-term resorbable, synthetic matrix, with dual stage mechanics, a new addition to the surgeon’s toolbox.

Stellan Bjorck, principle investigator for the clinical study of TIGR Matrix surgical mesh at Sahlgrenska University Hospital, Gothenburg, Sweden, said: “It is desirable to avoid leaving permanent foreign materials in the body. This provides us with a new tool to repair abdominal wall defects in a logical way.”

Davide Lomanto, president of the Asia-Pacific Hernia Society and Senior Consultant at National University Hospital, Singapore, said: “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.”

Thomas Engstrom, CEO and president of Novus, said: “We are excited to be able to introduce the TIGR Matrix surgical mesh to US surgeons, as the first in a line of synthetic resorbable medical devices.”