NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for its Cohere cervical interbody fusion device and that it launched the Coalesce thoracolumbar interbody fusion device.
Both the launch and updated clearance comes from the company’s acquisition of Vertera Spine, which it closed last September.
The Cohere and Coalesce implants use porous version of the material polyetheretherketone, or PEEK, and are designed to provide three-dimensional achitecture to elicit and encourage bone growth, San Diego, Calif.-based NuVasive said.
“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants. 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,” chair & CEO Gregory Lucier said in a prepared statement.
The company said that the Coalesce device is now available for TLIF and PLIF procedures in multiple footprints, heights and lordotic options. Its indications include use for one or two adjacent levels in the thoracolumbar spine with both autograft and allograft for treating degenerative disc disease and degenerative spondylolisthesis and multi-level degenerative scoliosis.
NuVasive said that the expanded FDA indications for its Cohere device clear it for use at multiple levels in the cervical spine with both autografts and allografts.
“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment. Cohere and Coalesce contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure,” Dr. Kenneth Burkus of The Hughston Clinic said in a press release.
Last month, NuVasive said it inked a deal to acquire intraoperative neurophysiological monitoring service provider SafePassage for an undisclosed amount.
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