NASS News: FDA Clears Cervical Corpectomy Cage From NuVasive

NuVasive Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance of its cervical corpectomy cage. The X-Core Mini Cervical Corpectomy System is an expandable titanium vertebral body replacement (VBR) device designed to provide enhanced stability following a corpectomy procedure. Compay executives touted the approval as a first-of-its kind clearance.

The announcement came just before the 30th annual meeting of the North American Spine Society in Chicago, Ill. (Oct. 14-17).

The NuVasive X-Core Mini Cervical Expandable VBR System (X-Core Mini VBR) is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture or osteomyelitis, in addition to the reconstruction following a corpectomy to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders, according to a company news release. X-Core Mini VBR is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. It also is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in terminally ill patients with advanced stage cervical spine tumors who are not suitable candidates for fusion.

“The X-Core Mini system allows the surgeon a choice of endcaps and core diameters, ensuring each construct is optimized to best address each patient’s individual surgical needs,” said Neill Wright, M.D., a neurosurgeon practicing at Barnes Jewish Hospital in St. Louis, Mo. “I have used X-Core Mini in degenerative, neoplastic, traumatic, and infectious cases. With so many options of size and endcap, in each case, from the more common single level to the rare five-level corpectomy, the X-Core Mini has fit perfectly and simply. The design of X-Core Mini, from connection of the endcaps to the core, to in-situ expansion, to locking, has proven to be straightforward, reproducible, durable and reliable. The large central channel allows for copious amount of graft material, and the large anterior window allows for augmentation with further graft after insertion and expansion.”

X-Core Mini must be used with supplemental fixation cleared by the FDA for use in the cervical spine, which includes San Diego, Calif.-based NuVasive’s newly released Archon Reconstruction Corpectomy plate. The Archon-R plate is designed to offer improved biomechanical rigidity and resistance to screw pullout when compared to a traditional two-hole plate construct and is a first-of-its kind indication by the FDA as particularly suited for use following corpectomies for the treatment of tumors and burst fractures, NuVasive bigwigs claim.

“This assembly of best-in-class cervical products into a cohesive procedural offering reinforces NuVasive’s commitment to providing single-source, integrated procedural solutions to our customers,” said Pat Miles, president and chief operating officer of NuVasive. “Combining X-Core Mini VBR and Archon Reconstruction plate provides another example of defining the components necessary to properly address an unmet market need.”

The Archon Reconstruction system incorporates technology developed by Gary K. Michelson, M.D., a billionaire inventor of surgical devices and a retired orthopedic surgeon who has devoted an estimated $300 million of his fortune to an assortment of causes including animal welfare, medical research, online textbooks and tropical rain forests.