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 Mesh received US FDA 510(k) clearance on 25th January 2010.
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 Headquarters 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). The US Division, Novus Scientific, Inc. is headquartered near Boston, one of the world’s foremost medical research cities. From this hub, Novus Scientific, Inc. will distribute TIGR® Matrix Surgical Mesh throughout the United States.
TIGR® is a registered trademark of Novus Scientific Pte. Ltd