NuVasive, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its thoracolumbar interbody portfolio to include the treatment of multi-level sagittal deformities of the thoracolumbar spine.
Nuvasive notes this clearance expands the portfolio’s indications from one- to two-level spine surgery, to now multiple levels, for the treatment of sagittal malalignment.
“NuVasive’s thoracolumbar interbodies are now the only implants on the market to be clinically validated in and indicated for the treatment of sagittal deformities,” said Massimo Calafiore, executive vice president, Global Business Units at NuVasive. “This clearance is reflective of NuVasive’s leadership in the field of global spinal alignment, and reflects the Company’s commitment to providing procedural solutions that help improve patient outcomes through the preservation and restoration of sagittal alignment.”
Sagittal deformities often result in significant pain and disability for patients and affect upright posture that is fundamental to normal human function. NuVasive’s thoracolumbar portfolio of static and expandable interbody implants—Cohere®, Modulus®, TLX®, MLX® and CoRoent®—are available in a variety of dimensions that allow for surgeon decision making based on the specific patient need and can significantly improve alignment in the sagittal plane. These implants also procedurally integrate with NuVasive’s enabling technologies, including:
- Integrated Global Alignment® (iGA®) platform, comprised of surgical planning tools—NuvaLine® and NuvaMap® O.R.—designed to enhance clinical and economic outcomes by increasing the predictability of achieving global alignment in spinal procedures through pre-, intra-, and postoperative measurement of alignment; and
- Bendini®, a proprietary, digital spinal rod bending system used to create patient-specific rods to effectively restore sagittal alignment.
“It is well accepted that restoration of spinal alignment, particularly in the sagittal plane, is associated with optimized clinical success and outcomes for patients,” said Adam Kanter, associate professor of neurological surgery and director of the Minimally Invasive Spine and fellowship programs at the University of Pittsburgh School of Medicine, in Pittsburgh, Pennsylvania. “This recent clearance for expanded indications provides broader scientific justification for not only sagittal deformity correction with these implants, but also their benefit in less invasive spine surgery.”