Novus Scientific's TIGR Matrix Surgical Mesh receives FDA marketing approval

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

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Keck Hospital of USC receives ninth "A" Hospital Safety Grade from The Leapfrog Group