NUVASIVE GETS FIRST FOUR-LEVEL CERVICAL FUSION CLEARANCE (Orthopedics This Week)
NuVasive, Inc. announced on March 29, 2017, that it is the first company to receive clearance from the FDA for intervertebral body fusion for up to four contiguous levels in the cervical spine.
Due to cervical radiculopathy and myelopathy secondary to cervical degenerative discs in adult patients, more than 200,000 cervical surgical procedures are performed in the U.S. each year, according to the American Association of Neurological Surgeons.
The FDA clearance is for the company's CoRoent Small Interbody System, which was cleared for one level from C2-T1 in September 2016.
The company says the system is an interbody cage manufactured from PEEK-Optima [polyether ether ketone] that provides "stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes ma...
