The FDA cleared NuVasive, Inc.’s use of its Cohere Porous PEEK implant in extreme lateral interbody fusion (XLIF) surgical spine procedures.
The October 5, 2018, clearance came less than three months after the company submitted its request.
Indications
According to the FDA’s clearance documents, the Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients.
“The system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.”
“The system is intended for use in interbody fusions in the thoracic spine from T1 to T12, at the thoracolumbar junction (T12-L1), and in the lumbar spine from L1 to S1 for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain).”
The system “…can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.”
Thoracolumbar Interbody System
According to the FDA documents, the system is comprised “ of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures.”
“Each device within the system is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more radiolucent markers, depending on footprint, to enable visibility under x-ray in vivo.
“The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.”
Porous PEEK
Christopher R. Brown, M.D., orthopedic spine surgeon for Duke Health, said incorporating the Cohere implants into XLIF procedures, “keeps imaging characteristics that we all love about PEEK implants intact [and] takes the gold standard of lateral interbody fusion and raises the bar, allowing our patients to receive the best surgery with the best implant possible.”
The company says its porous PEEK technology, “offers a unique three-dimensional architecture combined with the radiolucent properties of PEEK. Based on preclinical studies, this porous structure promotes bone ongrowth and ingrowth, which is key to facilitating fusion that leads to better clinical outcomes. This unique, proprietary technology – combined with the radiolucent properties of PEEK – provides increased clarity in postoperative x-rays and imaging, allowing surgeons to more easily assess fusion following procedures.”
Matt Link, president, Strategy, Technology and Corporate Development for NuVasive, said the “Cohere XLIF represents the first buildout of a porous PEEK implant by NuVasive.” He added the company intends to extend the proprietary technology into additional applications.
The company expects to launch Cohere XLIF in the U.S. in the second quarter of 2019.
