Novus Scientific receives CE Mark Approval for TIGR® Matrix Surgical Mesh - the World’s First Long-Term Resorbable Synthetic Mesh.

The CE Mark is yet another major milestone for Novus Scientific. This now gives general and plastic surgeons in Europe access to a brand new class of 100% resorbable synthetic mesh, which fills an important gap left between permanent meshes and biological products. Surgeons in Europe can now offer a new solution to patients where permanent mesh may pose a known or potential risk.

”All my patients have been very satisfied with the results achieved using TIGR® Matrix Surgical Mesh”, said Stellan Björck, MD, PhD, of Sahlgrenska University Hospital, Gothenburg, Sweden. Dr Björck was the Principle Investigator for the first clinical study of TIGR® Matrix Surgical Mesh. ”It is very desirable to avoid leaving permanent foreign materials in the body and thereby decrease the risk of long-term mesh related complications.”

“It might be the solution for something hernia surgeons are constantly looking for: a permanent wall reinforcement without forever-lasting synthetic materials” said Dr. F. Berrevoet, MD, PhD, Department of General and Hepatobiliary Surgery, University Hospital Ghent, Belgium.

“TIGR® Matrix is so unique and innovative that it will break the mould of the traditional surgical mesh market” said Tom Haeleydt, Sales and Marketing Development EMEA at Novus Scientific.

Novus Scientific recently had its Quality Management System certified to the requirements of ISO 13485:2003 by BSI  (The British Standards Institution), one of the world’s leading certification bodies. BSI also certified Novus Scientific to European Medical Device Directive 93/42/EEC which is required to place the CE mark on its products.

 TIGR® Matrix Surgical Meshreceived US FDA 510(k) clearance on 25th January 2010.

CONTACT:  
Mark Hawthorne: +44 7748 988705 - mark.hawthorne@novusscientific.com           
Tom Haeleydt: +32 475 72 06 70 – tom.haeleydt@novusscientific.com