Xtant Medical Holdings announced that the US Food and Drug Administration (FDA) has cleared the Irix-C cervical cage for use with autograft and/or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1.
Previously the device was cleared only for use with autogenous bone graft. This furthers Xtant Medical's goal of being a comprehensive supplier of products to spine surgeons.
Xtant Medical’s 3Demin and patented OsteoSponge technology are excellent allografts to use with Irix-C due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.
OsteoVive, a cellular allograft, can also be used in conjunction with Irix-C. This new clearance is indicative of common surgical practices of using allografts in cervical cages to promote fusion.
Dr. Gregory Juda, Chief Scientific Officer of Xtant Medical states, "This new FDA clearance allows Xtant Medical to leverage the clinical effectiveness of our established allograft product offerings for use with our stand-alone interbody devices in cervical discectomy and fusion procedures.
“We expect that the use of these products as a combined spinal fusion solution will result in positive patient outcomes."
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients for treatment of degenerative disc disease.
Xtant Medical estimates the worldwide market for cervical fusion devices at $1.3B and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. Irix-C, 3Demin, OsteoSponge, and OsteoVive are currently widely available.