Peer-reviewed data results from multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF
SAN DIEGO, Sept. 9, 2021 /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 one-level U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study data was recently published in the International Journal of Spine Surgery. The data was utilized in the device’s FDA pre-market application for one-level indication approval in September 2020.
The peer-reviewed study reiterates that the Simplify Cervical Disc has a significantly greater success rate at the 24-month follow up compared to anterior cervical discectomy and fusion (ACDF) when used in treatment for one-level cervical total disc replacement (cTDR).1 Findings from this study include:
- Mean Neck Disability Index (NDI), a patient-reported measure for disability related to cervical spinal disorders, was significantly lower for patients who underwent a cTDR with the Simplify Cervical Disc compared to ACDF;
- Range of motion significantly increased for cTDR patients treated with the Simplify Cervical Disc at three months and was maintained throughout follow ups; and
- Facet joint degeneration assessment by MRI showed little change from pre- to post-operation in the cTDR patients. This is the first time 24-month follow up MRI scans were used in an IDE study for cTDR.2 The Simplify Cervical Disc allows for enhanced visualization through MRI postoperatively compared to alternative devices, a key imaging modality in spine.
“This recent peer-reviewed publication validates the strong clinical data behind the Simplify Cervical Disc and why this is the most clinically effective technology in the cTDR procedure segment,” said Kyle Malone, vice president of Clinical, Medical, and Regulatory Affairs at NuVasive. “As we continue to pursue Simplify Cervical Disc clinical data, we are encouraged by these results to support our commitment to outcome-driven innovation in spine surgery that benefits surgeons, hospitals, and—most importantly—patients.”
The Simplify Cervical Disc is part of the NuVasive C360™ portfolio, which offers comprehensive, procedurally integrated solutions for the cervical spine across ACDF, posterior cervical fusion, and cTDR procedures. The device is designed with key performance functions that include a radiologic design, anatomic disc heights, and physiologic motion. Overall, the Simplify Cervical Disc demonstrates clinical superiority to ACDF3 and has the highest overall clinical success rate compared to any other approved cervical disc at both one- and two-levels.2 It is one of three devices approved for use in two-level cTDR procedures.2
“I am excited to see this study published on the Simplify Cervical Disc’s one-level FDA trial,” said Richard Guyer, MD, orthopedic spine surgeon and co-founder of the Texas Back Institute in Plano, Texas. “Not only were the disc’s results excellent for the cTDR procedure compared to fusion, but it also breaks new ground in cervical technology by offering a combination of smaller, more anatomic disc heights, reproducing a spine’s natural motion, and being entirely MRI compatible unlike other cTDR implants.”
This data will also be presented by Dr. Guyer at the following industry conferences with recognition in the best paper section for each respective meeting:
- North American Spine Society 36th Annual Meeting on Wednesday, September 29, 2021
- Cervical Spine Research Society 49th Annual Meeting on Saturday, December 4, 2021
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 has approximately 2,700 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 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 Guyer RD, Coric D, Nunley PD, et al. Single-level cervical disc replacement using a PEEK-on-ceramic implant: results of a multicenter FDA IDE trial with 24-month follow-up. Int J Spine Surg 2021;15(4):633-44.|
|2 Data on file. Based on review of publicly available materials at the time of this release.|
|3 Simplify Cervical Artificial Disc – P200022|
SOURCE NuVasive, Inc.