National University Hospital Singapore Receives DSRB Approval to Use TIGR®
Matrix Surgical Mesh in a New Randomized Controlled TRAM Flap Study
</pre> <p><span class="xn-location">SINGAPORE</span>, <span class="xn-chron">Sept. 13</span> /CNW/ -- Novus Scientific Pte. Ltd today announced that the National University Hospital (NUH), <span class="xn-location">Singapore</span> has received Domain Specific Review Board (DSRB i.e. IRB equivalent) provisional approval for a new study: Abdominal Wall Closure After Lipectomy, TRAM/DIEP Flap - Comparison of TIGR (100% Resorbable) vs Polypropylene (Permanent) Mesh.</p> <p/> <p>This is a randomized study, involving 86 patients. There are plans to expand this to a multi-site and possibly multi-centre study involving other hospitals in <span class="xn-location">Singapore</span> and in the U.S. TIGR® Matrix is the World's 1st Long-Term Resorbable Synthetic Mesh, which was launched for sale in the U.S. in <span class="xn-chron">June 2010</span>. In <span class="xn-chron">February 2010</span>, the US Food and Drug Administration (FDA) cleared, TIGR® Matrix Surgical Mesh for use in reinforcement of soft tissues where weakness exists.</p> <p/> <p>"TIGR® Matrix is potentially an ideal prosthesis for patients undergoing breast reconstruction via TRAM Flap, as only a temporary donor site reinforcement is needed. Unlike permanent meshes, TIGR® Matrix is a long-term, synthetic, resorbable product that can be used as prophylaxis against hernia formation, while reducing the potential risk of permanent mesh related complications," said Associate <span class="xn-person">Professor Thiam Chye Lim</span>, Principal Investigator & Head of Division of Plastic, Reconstructive and Aesthetic Surgery, National University Hospital, <span class="xn-location">Singapore</span>.</p> <p/> <p>TIGR® Matrix is 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 degraded and resorbed. The macroporous structure is designed to permit tissue integration for tissue repair.</p> <p/> <p>"Novus Scientific is very excited to collaborate with such a renowned institution as NUH and especially with an esteemed Principal Investigator like Associate <span class="xn-person">Professor TC Lim</span> and his team. We see TIGR® Matrix filling a gap between permanent synthetic and biological meshes - the best of both worlds. This study will potentially bring significant clinical benefits to patients undergoing breast and other soft-tissue reconstruction," said <span class="xn-person">Thomas Engstrom</span>, CEO & President of Novus Scientific.</p> <p/> <p>Reference Link: This study is listed in ClinicalTrials.gov a service of the U.S. National Institutes of Health under <a href="http://clinicaltrials.gov/ct2/show/NCT01136603?term=Tram&rank=2">http://clinicaltrials.gov/ct2/show/NCT01136603?term=Tram&rank=2</a></p> <pre> About Novus Scientific </pre> <p>Novus Scientific (<a href="http://www.novusscientific.com">www.novusscientific.com</a>) is an innovator in the development and commercialization of resorbable synthetic medical devices. Global HQ is in <span class="xn-location">Singapore</span> while European Headquarters and the core R&D function are in Uppsala, <span class="xn-location">Sweden</span>. 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 <span class="xn-location">Boston</span>, one of the world's foremost medical research cities. From this hub, Novus Scientific, Inc. will distribute TIGR® Matrix Surgical Mesh throughout the <span class="xn-location">United States</span>.</p> <pre> TIGR® is a registered trademark of Novus Scientific Pte. Ltd CONTACT: Tac-Whei Ong, [email protected], 65-68900360
For further information: Tac-Whei Ong, 65-68900360, [email protected] Web Site: http://www.novusscientific.com
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