Attrax Putty is the primary and solely artificial biologic to obtain 510(okay) clearance to be used with thoracolumbar interbody methods
SAN DIEGO, Jan. 5, 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, as we speak introduced the Firm acquired U.S. Food and Drug Administration (FDA) 510(okay) clearance for expanded indications of use for Attrax® Putty with its complete thoracolumbar interbody portfolio for backbone surgical procedure. Attrax Putty is the primary artificial biologic to obtain indications to be used in interbody fusions of the thoracolumbar backbone.
The NuVasive Attrax Putty is an artificial, bioactive and osteoconductive bone void filler designed to drive bone fusion. This proprietary, superior biomaterial incorporates a floor microarchitecture which supplies an optimized setting for bone formation with out added cells or development components. Attrax Putty is one in all only some bone grafting units available on the market supported by a Stage I randomized managed trial as a bone graft substitute in posterolateral spinal fusions.1 Current research 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 assist the scientific efficacy of Attrax Putty and spotlight the comparative scientific benefit over aggressive biologic choices out there,” mentioned Ryan Donahoe, chief expertise officer at NuVasive. “This primary and solely 510(okay) clearance of its sort demonstrates NuVasive’s dedication to advancing the usual of backbone care—whereas delivering enhanced financial worth to our prospects.”
With this clearance, Attrax Putty can now be used with NuVasive’s procedurally built-in thoracolumbar interbody portfolio that features the Superior Supplies Science™ (AMS) applied sciences of Modulus® porous titanium and Cohere® Porous PEEK™. These AMS implants are rooted in three key ideas of floor, construction, and imaging and designed to boost the osseointegration and biomechanical properties of implant supplies.4,5
“I’m excited to see the FDA recognizing that the scientific outcomes assist the secure and efficient use of those superior implant combos,” mentioned Robert Eastlack, MD, orthopedic backbone surgeon at Scripps Health in San Diego and board member of the San Diego Backbone Basis. “In my follow and scientific analysis, sufferers handled with optimized porous titanium cages like Modulus XLIF together with Attrax Putty have proven notable radiographic and scientific success. This implant mixture for spinal fusion has pushed cost-savings at my establishment whereas persevering with to offer scientific worth for my sufferers.”
About NuVasive 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 methods, biologics, software program for surgical planning, navigation and imaging options, magnetically adjustable implant methods for backbone and orthopedics, and intraoperative neuromonitoring expertise and repair choices. With greater than $1 billion in web gross sales, NuVasive has roughly 2,700 workers and operates in additional than 50 nations serving surgeons, hospitals, and sufferers. For extra info, please go to www.nuvasive.com.
Ahead-Trying Statements 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 components 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 embody, amongst others, dangers related to acceptance of the Firm’s surgical merchandise and procedures by backbone surgeons and hospitals, improvement and acceptance of recent merchandise or product enhancements, scientific and statistical verification of the advantages achieved by way of using NuVasive’s merchandise, the Firm’s capacity to adequately handle stock because it continues to launch new merchandise, its capacity 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 replicate occasions 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 managed, non-inferiority trial. Backbone 2020;45(14):944-51. 2 Malone H, Mundis GM, Collier M, et al. A novel strategy to evaluating lateral lumbar interbody fusion utilizing a 3D-Printed Porous Titanium Interbody System. 27th Worldwide Assembly on Superior Backbone Methods. On-line. July-August, 2020. 3 Menezes C. Attrax Putty vs. autograft in XLIF: A potential, randomized, single-center analysis of radiographic and scientific outcomes. Society for Minimally Invasive Backbone Surgical procedure Annual Discussion board 21. Las Vegas, NV. October 28-30, 2021. 4 Preclinical knowledge on file. Information might not be consultant of scientific outcomes. TR 9604787. 5 Consultant coupon, preclinical knowledge on file. Information might not be consultant of scientific outcomes. TR 9604781.