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SAN DIEGO, June 17, 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 commercial launch of Modulus® TLIF-O, a porous titanium spine implant engineered for the transforaminal lumbar interbody fusion (TLIF) procedure. This further expands the application of the Company's Advanced Materials Science™ (AMS) portfolio to more of its procedural offerings and the most commonly performed procedure in the spine industry.
Modulus TLIF-O features porous surface technology that, based on pre-clinical data, provides a favorable environment for bone in-growth and bone on-growth, and consistently achieves stronger osseointegration than solid implants with smooth or rough surfaces.1-4 The porous and roughened endplate design promotes new bone on-growth at four weeks and demonstrates the greatest integration strength by 12 weeks compared to alternative implant materials.5 Modulus TLIF-O's lattice structure is optimized for each implant size through NuVasive's proprietary algorithm that balances strength and radiolucency, while also mimicking the stiffness of bone.5 This optimized lattice structure enables enhanced imaging for visualization of spinal fusion compared to solid titanium interbody implants. Modulus TLIF-O's lordosis cut in the oblique plane, along with the ability to insert and rotate or impact the implant using the same instrumentation, enables surgeons to restore sagittal alignment of the spine while avoiding introduction of an undesired coronal misalignment.
"Modulus TLIF-O offers multiple lordotic options allowing even the most hyperlordotic cages to be delivered through a minimally invasive surgical approach due to the implant design and customized instrumentation," said Ronjon Paul, MD, an orthopedic surgeon at The Spine Center of DuPage Medical Group in Illinois. "Modulus' uniquely optimized lattice structure and porous surface technology pair well with biologic components to aid in the fusion process."
Adhering to the AMS core principles of surface, structure and imaging, NuVasive continues to pioneer design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of polyetheretherketone (PEEK) and titanium. This provides surgeons with a portfolio of advanced material implant options that best fit their patient's needs.
"The Modulus implant location and orientation can clearly be visualized in the disc space. This is extremely helpful in the OR to educate my trainees, in the clinic to inform my patients and staff, and in the database for our research and hospital outcomes administrators. Modulus is a winning situation for all," said Adam S. Kanter, MD, neurosurgeon at University of Pittsburgh Medical Center.
Later this summer, the Company plans to launch the Modulus TLIF-A spine implant. This integrates the Modulus surface technology with a specific design for anterior implant positioning for the TLIF procedure.
"Modulus TLIF-O represents our continued commitment to delivering best-in-class implants that enable our surgeon partners to overcome common challenges faced in traditional posterior procedures," said Matt Link, president of NuVasive. "The proprietary engineering behind Modulus is advancing the science of spine implant surface technology and helping improve a patient's fusion rates and overall clinical outcomes."
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.
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.
1Cheng A, Cohen DJ, Kahn A, et al. Laser sintered porous Ti-6Al-4V implants stimulate vertical bone growth. Ann Biomed Eng 2017;45(8):2025-35.
2Guyer RD, Abitbol JJ, Ohnmeiss DD, et al. Evaluating osseointegration into a deeply porous titanium scaffold: A biomechanical comparison with PEEK and allograft. Spine 2016;41(19):E1146-50.
3Svehla M, Morberg P, Zicat B, et al. Morphometric and mechanical evaluation of titanium implant integration: comparison of five surface structures. J Biomed Mater Res 2000;51(1):15-22.
4Torstrick 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.
5Preclinical data on file. Data may not be representative of clinical results. TR 9604787
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SOURCE NuVasive, Inc.