NuVasive announced on 4 January the launch of the company’s Coalesce Thoracolumbar Interbody Fusion Device as well as FDA 510(k) clearance for expanded indications of its Cohere Cervical Interbody Fusion Device. The launch and updated claims follow the NuVasive September 2017 acquisition of Vertera Spine, developers of interbody implants for spinal fusion using patented porous polyetheretherketone (PEEK) technology.
The NuVasive Advanced Materials Science (AMS) Portfolio includes Porous PEEK and Modulus Titanium interbody implants that are engineered for enhanced osseointegration and biomechanical properties when compared to solid implants with smooth or rough surfaces. Based on animal studies, Coalesce and COHERE provide a unique three-dimensional Porous PEEK architecture to help elicit and encourage bone ingrowth. The technology used to develop these devices utilizes a proprietary processing method that introduces porous structure without compromising implant strength.
“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualisation properties of these implants,” said Gregory T Lucier, chairman and chief executive officer of NuVasive. “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.”
Coalesce is now commercially available for TLIF and PLIF procedures in multiple footprint, height and lordotic options, and is magnetic resonance compatible. Following its recently cleared 510(k), Coalesce indications have been expanded to include use for one or two adjacent levels in the thoracolumbar spine (T1–S1) with both autograft and allograft for treatment of degenerative disc disease and degenerative spondylolisthesis as well as multilevel degenerative scoliosis. The device previously received FDA 510(k) clearance for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.
The expanded FDA 510(k) indications for Cohere allow it to be used at multiple levels in the cervical spine (C2–T1) with both autograft and allograft. In addition, Cohere received a new ICD code from the Center of Medicare & Medicaid Services (CMS) in October. Cohere is the only product approved for use with the new code, signifying CMS’ recognition of the innovation and potential clinical and tracking benefits of using porous PEEK technology.
“Patients can gain significant pain relief and improved functional outcomes through the stabilisation and fusion of the degenerated spinal motion segment,” said Kenneth Burkus, orthopaedic 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.”