FDA Grants 510(k) Green Light for ETEX Corp.’s CarriGen

ETEX Corp. is launching porous bone substitute material CarriGen at the American Academy of Orthopaedic Surgeons Annual Meeting. This comes after the Cambridge, Mass., firm received 510(k) approval by the U.S. Food and Drug Administration.

CarriGen, which is a highly porous bone graft substitute that sets hard upon implantation for a complete defect fill, according to the company, builds upon the clinically proven benefit of ETEX nanocrystalline calcium phosphate technology by adding the advantage of increased porosity and pore size. CarriGen is meant to be a bone void filler of the pelvis, extremities and spine, including posterolateral spine fusion, the company said.

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 Level 1 clinical trial, according to the company.

Brian Ennis, president and CEO of ETEX Corp., said: “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 Corp. develops, manufactures and commercializes calcium phosphate-based biomaterials for improved orthopedic clinical outcomes.