NuVasive Receives FDA Clearance for Expanded Indications of Use for Attrax Putty with Company's Thoracolumbar Interbody Portfolio

Rhea-AI Summary

NuVasive (NASDAQ: NUVA) announced FDA 510(k) clearance for expanded indications of use for Attrax^® Putty, marking it as the first synthetic biologic approved for thoracolumbar spine interbody fusions. This innovative bone void filler exhibits osteoconductive properties and competes favorably with autograft bone in clinical studies. The clearance enables its use with NuVasive's Advanced Materials Science portfolio, enhancing spine surgery solutions. The company's commitment to advancing spine care aims to deliver both clinical efficacy and economic value.

Positive

• FDA clearance for Attrax Putty expands its usage in thoracolumbar interbody fusions.
• Attrax Putty is a first-of-its-kind synthetic biologic in this application.
• Demonstrates comparable clinical outcomes to traditional autograft bone.
• Integration with NuVasive's Advanced Materials Science portfolio enhances surgical solutions.

Negative

• None.

SAN DIEGO, Jan. 5, 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 Company received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications of use for Attrax^® Putty with its comprehensive thoracolumbar interbody portfolio for spine surgery. Attrax Putty is the first synthetic biologic to receive indications for use in interbody fusions of the thoracolumbar spine.

The NuVasive Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler designed to drive bone fusion. This proprietary, advanced biomaterial features a surface microarchitecture which provides an optimized environment for bone formation without added cells or growth factors. Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.¹ Recent studies have demonstrated that Attrax Putty performs comparably to autograft bone in thoracolumbar interbody fusions.^2,3

"The expanded indications of Attrax Putty with thoracolumbar implants support the clinical efficacy of Attrax Putty and highlight the comparative clinical advantage over competitive biologic offerings in the market," said Ryan Donahoe, chief technology officer at NuVasive. "This first and only 510(k) clearance of its kind demonstrates NuVasive's commitment to advancing the standard of spine care—while delivering enhanced economic value to our customers."

With this clearance, Attrax Putty can now be used with NuVasive's procedurally integrated thoracolumbar interbody portfolio that includes the Advanced Materials Science™ (AMS) technologies of Modulus^® porous titanium and Cohere^® Porous PEEK™. These AMS implants are rooted in three key principles of surface, structure, and imaging and designed to enhance the osseointegration and biomechanical properties of implant materials.^4,5

"I'm excited to see the FDA recognizing that the clinical results support the safe and effective use of these advanced implant combinations," said Robert Eastlack, MD, orthopedic spine surgeon at Scripps Health in San Diego and board member of the San Diego Spine Foundation. "In my practice and clinical research, patients treated with optimized porous titanium cages like Modulus XLIF in combination with Attrax Putty have shown notable radiographic and clinical success. This implant combination for spinal fusion has driven cost-savings at my institution while continuing to provide clinical value for my patients."

About NuVasive
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.

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 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 Lehr MA, Oner CF, Delawi D, et al. Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Spine 2020;45(14):944-51.
² Malone H, Mundis GM, Collier M, et al. A novel approach to evaluating lateral lumbar interbody fusion using a 3D-Printed Porous Titanium Interbody Device. 27^th International Meeting on Advanced Spine Techniques. Online. July-August, 2020.
³ Menezes C. Attrax Putty vs. autograft in XLIF: A prospective, randomized, single-center evaluation of radiographic and clinical outcomes. Society for Minimally Invasive Spine Surgery Annual Forum 21. Las Vegas, NV. October 28-30, 2021.
⁴ Preclinical data on file. Data may not be representative of clinical results. TR 9604787.
⁵ Representative coupon, preclinical data on file. Data may not be representative of clinical results. TR 9604781.

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvasive-receives-fda-clearance-for-expanded-indications-of-use-for-attrax-putty-with-companys-thoracolumbar-interbody-portfolio-301454191.html

SOURCE NuVasive, Inc.

FAQ

What recent FDA clearance did NuVasive receive?

NuVasive received FDA 510(k) clearance for expanded use of Attrax Putty in thoracolumbar spine interbody fusions.

What is Attrax Putty?

Attrax Putty is a synthetic, bioactive bone void filler designed to promote bone fusion in spine surgery.

How does Attrax Putty compare to autograft bone?

Recent studies indicate that Attrax Putty performs comparably to autograft bone in spinal fusions.

What advantages does Attrax Putty offer in spine surgery?

Attrax Putty provides enhanced clinical efficacy and economic value while being the first synthetic biologic approved for specific spine procedures.

What is NuVasive's mission?

NuVasive aims to transform surgery, advance care, and change lives through innovative spine technology.