SAN DIEGO – November 9, 2020 – NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, 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. This clearance expands the portfolio’s indications to include multilevel sagittal deformity.
“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 interbody implants—Cohere®, Coalesce®, Modulus®, BASE®, Brigade®, 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.”
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes access, implants and fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With more than $1 billion in net sales, NuVasive has approximately 2,800 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.