Monday, April 09, 2007
Atrium Medical Receives FDA Approval for its Novel C-QURLite(TM) Mesh
HUDSON, N.H., April 9 /PRNewswire/ -- Atrium Medical Corporation ispleased to announce it has obtained US FDA 510(K) approval for a new Omega3 surgical mesh product called C-QURLite(TM) Mesh. This new product is indicated for use in the surgical repair andreinforcement of soft tissue, including hernia repair -- a common procedureperformed more than 700,000 times in the US each year. This noveltechnology combines Atrium's ProLite Ultra(TM) polypropylene surgical meshwith a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbablegel coating. Unlike traditional tissue separating mesh products, C-QURLiteMesh enhances the handling stiffness and healing response in pre-peritonealplacement when compared to other "bare" polymer mesh products currentlyused for hernia repair. C-QURLite Mesh is constructed from the refined ProLite Ultrapolypropylene monofilament, providing a low profile, strong, lightweightbase structure. The novel all natural Omega 3 gel coating is then appliedin a proprietary method, coating each monofilament of the mesh to enhancematerial handling and subsequent healing. This non-polymeric,bio-absorbable coating has demonstrated in pre-clinical studies tosignificantly improve anatomical conformance by reducing aggressive, denseacellular collagen formation known to induce adhesions following surgery. Atrium's discovery of combining inert thin wall polypropylene mesh withan Omega 3 biological coating in pre-clinical studies has demonstratedminimization of peritoneal tissue attachment as well as a significantreduction in both foreign body reaction and inflammation, resulting in awell healed, reinforced soft tissue repair. The novel C-QURLite Mesh BAOcoating (BioAbsorbable Oil) also enhances ease of handling and tissue planeplacement, which subsequently forms into an elegant soft and flexibleimplant. It offers improved stiffness and handling qualities preferred bymany of today's discriminating surgeons while maintaining excellentsee-thru visibility to underlying tissue landmarks for improved anatomicalorientation during surgical installation. The use of Atrium's all natural Omega 3 bio-absorbable coating with itsadvanced lightweight surgical mesh provides today's clinicians with a broadspectrum of options for both laparoscopic and open surgical repair. Thisfirst to market BAO coating technology enables cells to freely grow throughthe porous mesh implant during healing immediately following soft tissuerepair. Atrium's C-QURLite Mesh will be available in a wide variety ofpreferred anatomical laser cut shapes and sizes mid-year 2007. About Atrium Atrium's vast expertise in medical device technologies for thetreatment of cardiovascular disease, hernia and adhesion prevention hasbrought a number of breakthrough advances in several diversified healthcaremarkets including interventional cardiology and radiology, chest traumacare and thoracic drainage, vascular surgery, and soft tissue repair.Maintaining a commitment to the latest ISO13485 Quality Standards,state-of-the-art manufacturing and automation, cell biology and biomaterialdiscovery programs, Atrium continues to excel in those healthcare segmentsthat require more advanced surgical intervention for improvements inpatient outcome. For more information call 800-370-7899 or visit Atrium'swebsite http://www.atriummed.com.
SOURCE Atrium Medical Corporation
SOURCE Atrium Medical Corporation
Posted by IHRT at 4/09/2007 08:00:00 AM