Peer-reviewed outcomes from the two-level multi-center FDA Investigational Gadget Exemption research reiterate disc’s superiority to ACDF
SAN DIEGO, April 21, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the chief in backbone expertise innovation, targeted on remodeling backbone surgical procedure with minimally disruptive, procedurally built-in options, at the moment introduced the NuVasive Simplify® Cervical Disc (Simplify Disc) two-level U.S. Food and Drug Administration (FDA) Investigational Gadget Exemption (IDE) research information was not too long ago printed within the Journal of Neurosurgery: Backbone. The information have been utilized within the machine’s FDA pre-market utility for two-level indication approval, which was authorized in April 2021.
The peer-reviewed publication reiterates that the Simplify Disc has a considerably better success price on the 24-month comply with up in comparison with anterior cervical discectomy and fusion (ACDF) when used for two-level cervical whole disc substitute (cTDR).1 Findings from this research embrace:
- General composite success price was statistically considerably better within the cTDR group in comparison with the ACDF group at 24-month comply with up;
- Imply Neck Incapacity Index (NDI), a patient-reported measure for incapacity associated to cervical spinal issues, scores improved considerably in each teams, with the cTDR group having decrease scores in any respect follow-up factors;
- Neck and arm ache scores improved considerably in each the cTDR and ACDF teams; and
- Fee of subsequent surgical intervention was decrease within the cTDR group in comparison with the ACDF group.
“This peer-reviewed publication provides to the rising physique of medical proof in help of the Simplify Disc,” stated Kyle Malone, vice chairman of Scientific Affairs at NuVasive. “The Simplify Disc continues to show superiority compared to various strategies. As the best expertise within the cTDR process phase, we’re excited for the differentiated expertise to assist extra sufferers across the globe.”
The Simplify Disc is a part of the NuVasive C360™ portfolio, which provides complete, procedurally built-in options for the anterior and posterior cervical backbone, together with ACDF, cTDR and posterior cervical fusion (PCF) procedures. The Simplify Disc is designed to supply surgeons best-in-class capabilities for cTDR throughout key efficiency features that embrace anatomic disc heights, physiologic movement and a radiologic design. General, the Simplify Disc demonstrates medical superiority to ACDF and has the very best general medical success price in comparison with every other authorized cervical disc for two-level use.2
“I’m excited to see the excellent medical and radiographic outcomes of the Simplify Disc’s two-level IDE added to the rising physique of Degree I proof supporting the protection and efficacy of cervical arthroplasty,” stated Domagoj Coric, MD, orthopedic backbone surgeon and chief of neurosurgery at Carolinas Medical Heart.
This information will likely be offered by Dr. Coric on the following trade convention with recognition in the perfect paper part:
- Worldwide Society for the Development of Backbone Surgical procedure 22nd Annual Convention on Friday, June 3, 2022.
Click on right here to be taught extra in regards to the Simplify Disc.
NuVasive, Inc. (NASDAQ: NUVA) is the chief in backbone expertise innovation, with a mission to rework surgical procedure, advance care, and alter lives. The Firm’s less-invasive, procedurally built-in surgical options are designed to ship reproducible and clinically confirmed outcomes. The Firm’s complete procedural portfolio contains surgical entry devices, spinal implants, fixation programs, biologics, software program for surgical planning, navigation and imaging options, magnetically adjustable implant programs for backbone and orthopedics, and intraoperative neuromonitoring expertise and repair choices. With greater than $1 billion in internet gross sales, NuVasive operates in additional than 50 nations serving surgeons, hospitals, and sufferers. For extra data, please go to www.nuvasive.com.
NuVasive cautions you that statements included on this information launch that aren’t an outline of historic information are forward-looking statements that contain dangers, uncertainties, assumptions and different elements which, if they don’t materialize or show appropriate, may trigger NuVasive’s outcomes to vary materially from historic outcomes or these expressed or implied by such forward-looking statements. The potential dangers and uncertainties which contribute to the unsure nature of those statements embrace, amongst others, dangers related to acceptance of the Firm’s surgical merchandise and procedures by backbone surgeons and hospitals, growth and acceptance of recent merchandise or product enhancements, medical and statistical verification of the advantages achieved by way of using NuVasive’s merchandise, the Firm’s potential to adequately handle stock because it continues to launch new merchandise, its potential to recruit and retain administration and key personnel, and the opposite dangers and uncertainties described in NuVasive’s information releases and periodic filings with the Securities and Trade Fee. NuVasive’s public filings with the Securities and Trade Fee can be found at www.sec.gov. NuVasive assumes no obligation to replace any forward-looking assertion to mirror occasions or circumstances arising after the date on which it was made.
1 Coric D, Guyer R, Bae H, et al. Potential, Multicenter Examine of Two-level Cervical Arthroplasty with a PEEK-on-Ceramic Synthetic Disc. Journal of Neurosurgery: Backbone 2021;1-11. doi: 10.3171/2022.1.SPINE211264. On-line forward of print.
2 Knowledge on file. Based mostly on evaluate of publicly accessible supplies on the time of this launch.
SOURCE NuVasive, Inc.