Clinical Study Demonstrates NuVasive Cohere® Porous PEEK™ Spinal Interbody Promotes Improved Early Outcomes Over Structural Allograft And Smooth PEEK
Apr 22, 2019, 08:30 ET
SAN DIEGO, April 22, 2019 /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 results of the study "Early Clinical Outcomes Comparing Porous PEEK, Smooth PEEK, and Structural Allograft Interbody Devices for Anterior Cervical Discectomy and Fusion," published online in the Journal of Spine & Neurosurgery, which concludes that the NuVasive proprietary Cohere® Porous polyetheretherketone (PEEK) implant demonstrates a clear benefit in promoting improved early outcomes over structural allograft and smooth PEEK in anterior cervical discectomy and fusion (ACDF) procedures.
In the study, 167 patients presenting with degenerative cervical disc disease underwent ACDF using Cohere Porous PEEK™, structural allograft or smooth PEEK in the interbody space. Patients receiving Cohere exhibited significant clinical improvements relative to preoperative (pre-op) scores, better outcomes than alternative treatments as early as six weeks and sustained improvements relative to other treatments through 12-months post-op.
As cited in the study's results, patients who were treated with Cohere Porous PEEK interbody fusion devices achieved clear improvements in neck disability index (NDI) scores and pain by six-weeks post-op, while patients treated with smooth PEEK showed significant improvements starting at three-months post-op. While structural allograft patients began to improve over baseline by six weeks, Porous PEEK patients showed statistically significant improvements over baseline by two weeks and significantly greater improvements than allograft and smooth PEEK patients by six-weeks post-op. This early improvement was maintained at all reported post-op time points out to one-year post-op.
"This is the first comparative study between NuVasive's Cohere Porous PEEK, smooth PEEK and allograft interbody spacers in ACDF, and it was found that patients treated with a Porous PEEK implant experienced incrementally improved early clinical improvements, which were sustained through the course of the study," said Kyle Malone, senior director of Medical Affairs at NuVasive. "Studies like this both corroborate the preclinical data as well as reaffirm NuVasive's commitment to clinical research and the necessity of having this as part of the product development process so we continually offer surgeons the best, most clinically proven technologies for their patients."
Cohere Porous PEEK provides a unique three-dimensional porous architecture designed to elicit and encourage bone in-growth1 and stabilization without compromising implant strength or radiolucency. NuVasive incorporated the proprietary technology, which is validated with more than 10 years of scientific research, after acquiring Vertera Spine in September 2017.
Porous PEEK web page:
https://www.nuvasive.com/solutions/advanced-materials-science/porous-peek-technology/
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems 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 revenues, NuVasive has approximately 2,600 employees and operates in more than 50 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.
Forward-Looking Statements
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.
1Torstrick FB, Safranski DL, Burkus JK, et al. Getting PEEK to stick to bone: The development of porous PEEK for interbody devices. Tech Orthop 2017;32(3):9.
SOURCE NuVasive, Inc.
