ETEX Corporation, an advanced biomaterials company, announced today that the FDA has granted 510(k) clearance of CarriGen Porous Bone Substitute Material. CarriGen is available for immediate sale through ETEX's independent sales force. CarriGen builds upon the clinically proven benefit of ETEX nanocrystalline calcium phosphate technology by adding the advantage of increased porosity and pore size. CarriGen is the first highly porous bone graft substitute that sets hard upon implantation for a complete defect fill.
CarriGen is indicated as a bone void filler of the pelvis, extremities and spine, including posterolateral spine fusion.
Cleared to be hydrated with saline or blood, CarriGen viscous putty may be injected or molded to pack into a defect. Upon implantation, CarriGen sets hard to provide compressive strength comparable to cancellous bone. The resulting osteoconductive scaffold provides interconnected porosity that facilitates cell mediated remodeling at the same rate as the surrounding bone. The proprietary nanocrystalline calcium phosphate technology, which serves as the foundation of the osteoconductive scaffold, has proven to be safe and effective in more than 10,000 implantations and a landmark Level 1 clinical trial.
ETEX is launching CarriGen at the American Academy of Orthopaedic Surgeons (AAOS) meeting in New Orleans, March 10-12, 2010. Attendees at ETEX booth #2569 will see demonstrations of this new biomaterial as well as clinical presentations on the use of ETEX technology in trauma and spine surgery.
Brian Ennis, President and CEO of ETEX Corporation, comments: "We are extremely pleased to announce the market release of CarriGen. While a number of respective bone growth factors continue to populate the market landscape, none of them possess any intrinsic biomechanical characteristics nor do they possess a biologically compatible scaffold that optimizes user handling and placement. ETEX has devoted more than a decade of research efforts to formulate carrier technology for bone growth factors utilizing our clinically proven conductive scaffold in formats that combine easy mixing with extraordinary handling capabilities. CarriGen represents just the first step in our concerted ongoing efforts to establish ETEX as the market leader in carrier technology."