Peer-reviewed results from the two-level multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF
SAN DIEGO, April 21, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Disc (Simplify Disc) two-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study data was recently published in the Journal of Neurosurgery: Spine. The data were utilized in the device’s FDA pre-market application for two-level indication approval, which was approved in April 2021.
The peer-reviewed publication reiterates that the Simplify Disc has a significantly greater success rate at the 24-month follow up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR).1 Findings from this study include:
- Overall composite success rate was statistically significantly greater in the cTDR group compared to the ACDF group at 24-month follow up;
- Mean Neck Disability Index (NDI), a patient-reported measure for disability related to cervical spinal disorders, scores improved significantly in both groups, with the cTDR group having lower scores at all follow-up points;
- Neck and arm pain scores improved significantly in both the cTDR and ACDF groups; and
- Rate of subsequent surgical intervention was lower in the cTDR group compared to the ACDF group.
“This peer-reviewed publication adds to the growing body of clinical evidence in support of the Simplify Disc,” said Kyle Malone, vice president of Scientific Affairs at NuVasive. “The Simplify Disc continues to demonstrate superiority in comparison to alternative techniques. As the most effective technology in the cTDR procedure segment, we are excited for the differentiated technology to help more patients around the globe.”
The Simplify Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the anterior and posterior cervical spine, including ACDF, cTDR and posterior cervical fusion (PCF) procedures. The Simplify Disc is designed to offer surgeons best-in-class capabilities for cTDR across key performance functions that include anatomic disc heights, physiologic motion and a radiologic design. Overall, the Simplify Disc demonstrates clinical superiority to ACDF and has the highest overall clinical success rate compared to any other approved cervical disc for two-level use.2
“I am excited to see the outstanding clinical and radiographic results of the Simplify Disc’s two-level IDE added to the growing body of Level I evidence supporting the safety and efficacy of cervical arthroplasty,” said Domagoj Coric, MD, orthopedic spine surgeon and chief of neurosurgery at Carolinas Medical Center.
This data will be presented by Dr. Coric at the following industry conference with recognition in the best paper section:
- International Society for the Advancement of Spine Surgery 22nd Annual Conference on Friday, June 3, 2022.
Click here to learn more about the Simplify Disc.
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 surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive 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 and hospitals, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products, the Company’s ability to adequately 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.
1 Coric D, Guyer R, Bae H, et al. Prospective, Multicenter Study of Two-level Cervical Arthroplasty with a PEEK-on-Ceramic Artificial Disc. Journal of Neurosurgery: Spine 2021;1-11. doi: 10.3171/2022.1.SPINE211264. Online ahead of print.
2 Data on file. Based on review of publicly available materials at the time of this release.
SOURCE NuVasive, Inc.