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NuVasive announces expanded FDA clearance of thoracolumbar, cervical interbody fusion devices
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NuVasive Inc. announced an expanded FDA 510(k) clearance for the Coalesce thoracolumbar interbody fusion device and Cohere cervical interbody fusion device for multilevel cases from C2-T1.
According to a company press release, both devices offer 3-D porous polyetheretherketone (PEEK) architecture to encourage bone ingrowth. The indications of use for the Coalesce have been expanded to include one or two adjacent levels in the thoracolumbar spine with both autograft and allograft for degenerative disc disease, degenerative spondylolisthesis and multilevel degenerative scoliosis.
Expanded FDA 510(k) indications for the Cohere include use at multiple levels in the cervical spine with both autograft and allograft. In October 2017, the Cohere received a new CMS International Classification of Disease code. It is reportedly the only device approved for use with this code.
“Our strategy in building our [advanced materials science] AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants,” Gregory T. Lucier, chairman and CEO of NuVasive, said in the release. “Our launch of Coalesce and the expanded clearance of Cohere and Coalesce are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life.”
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