NuVasive Extends Porous PEEK Interbody to TLIF, PLIF
Elizabeth Hofheinz, M.P.H., M.Ed. • Mon, January 15th, 2018
San Diego, California-based NuVasive, Inc. has announced the launch of the its COALESCE Thoracolumbar Interbody Fusion Device as well as FDA 510(k) clearance for expanded indications of its COHERE Cervical Interbody Fusion Device.
According to Gregory T. Lucier, chairman and chief executive officer of NuVasive, "Our strategy in building our AMS [advanced materials science] 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."
"Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment," said Dr. Kenneth Burkus, 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 [polyetheretherketone] implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure."
Lucier told OTW, “The new ICD [International Classification of Diseases] code for COHERE highlights what many in the industry already know: NuVasive is bringing game-changing, comprehensive spine solutions to market. As the first and only porous PEEK product to receive the code, it underscores the innovative technology driving our proprietary porous PEEK solutions and opens the door for future technology introductions.”
“COALESCE has a proprietary manufacturing process that creates a unified porous-to-solid structure designed for bone in-growth. Patients and surgeons will benefit from the expanded indications allowing COALESCE to be used in the thoracolumbar spine for one or two adjacent levels and the flexibility to use open or minimally-invasive TLIF [transforaminal lumbar interbody fusion] and PLIF [posterior lumbar interbody fusion] approaches. This launch is part of NuVasive’s continued commitment to bring disruptive technology to market, provide a better surgical experience and improve patient quality of life.”