NuVasive launched the Coalesce Thoracolumbar Interbody Fusion Device and expanded FDA 510(k) clearance for Coalesce and its Cohere Cervical Interbody Fusion Device on Jan 4.
Here are five things to know:
- Coalesce and Cohere provide a three-dimensional porous PEEK architecture to help encourage bone growth. To develop these devices, NuVasive used a proprietary processing method that introduced a porous structure without weakening the implant.
- Coalesce is now commercially available for transforaminal lumbar interbody fusion and posterior lumbar interbody fusion procedures in multiple footprint, height and lordotic options and is magnetic resonance compatible.
- The expanded FDA 510(k) indications allow surgeons to use Coalesce at one or two adjacent levels in the thoracolumbar spine (T1-S1) with both autograft and allograft for treatment of degenerative disc disease, degenerative spondylolisthesis and multi-level degenerative scoliosis. The FDA also expanded indications for Cohere at multiple levels in the cervical spine (C2-T1) with autograft and allograft.
- Coalesce previously received FDA 510(k) clearance for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.
- In Oct. 2017, the CMS gave Cohere a new ICD-10 code. Cohere is the only product approved for use with the new code, an XRG code listed as "Interbody Fusion Device, Radiolucent Porous."
"Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment," said Kenneth Burkus, MD, an orthopedic surgeon at The Hughston Clinic. "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."
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