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Etex Receives FDA Clearance For Carrigen

Etex Corp, an advanced biomaterials company, has received FDA 510(k) clearance for CarriGen Porous Bone Substitute Material.

Etex said that its CarriGen builds upon the clinically proven benefit of Etexnanocrystalline calcium phosphate technology by adding the advantage of increased porosity and pore size. CarriGen is the 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 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.

Brian Ennis, president and CEO of Etex, said: “We are 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.

“Etexhas 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.”