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Company announces FDA 510(k) clearances for the Modulus ALIF and Cohere TLIF-O.
May 5, 2020
By: PR Newswire
NuVasive Inc., the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the expansion of its Advanced Materials Science (AMS) implant portfolio with the commercial launch of the Modulus XLIF Dual Sided Plate, and the receipt of 510(k) clearances from the U.S. Food and Drug Administration (FDA) for Modulus ALIF and Cohere TLIF-O. “With these new offerings, NuVasive strengthens its AMS portfolio to equip surgeons with best-in-class technology for a variety of thoracolumbar procedures,” said Matt Link, president of NuVasive. “NuVasive’s continued R&D initiatives underscore the company’s commitment to expand within key procedural spine segments and deliver differentiated technology to support better patient outcomes.” The NuVasive AMS implant portfolio consists of proprietary surface and structural technologies to enhance the osseointegration and biomechanical properties of surgical materials used in spine procedures. Adhering to the core principles of surface, structure and imaging, NuVasive’s Modulus and Cohere implants are designed for fusion, combining the inherent benefits of porosity with the advantageous material properties of titanium and PEEK, respectively. The NuVasive Modulus XLIF Dual Sided Plate is a low-profile, anti-migration plate that allows for two points of fixation in eXtreme Lateral Interbody Fusion (XLIF) surgeries. This implant builds upon NuVasive’s Modulus XLIF plate portfolio, providing individualized solutions at the discretion of the surgeon, particularly in multi-stage procedures or in the event of anterior longitudinal ligament release. Additionally, simplified instrumentation allows surgeons to place the plate before or after insertion of the Modulus XLIF implant. “Since using the Modulus XLIF implant, I have seen extremely favorable clinical results with my patients,” said Mark Wang, orthopedic spine surgeon at Spine Institute of Arizona. “Now, with the dual sided plate, I can use Modulus XLIF and add a plate when the patient and pathologic features call for it. NuVasive’s comprehensive portfolio equips me with the appropriate tools to meet the needs of my patients.” Further rounding out the Modulus implant portfolio, NuVasive recently received 510(k) clearance of Modulus ALIF, a porous titanium implant engineered for the anterior lumbar interbody fusion (ALIF) procedure. Modulus ALIF is a low-profile implant designed for use in both supine and lateral ALIF (XALIF)—a key component of the X360 system—and is the company’s first AMS offering for the ALIF market. Additionally, the company received 510(k) clearance of Cohere TLIF-O, a porous PEEK implant engineered for the transforaminal lumbar interbody fusion (TLIF) procedure. Cohere TLIF-O includes NuVasive’s single-step insert and rotate technique as well as a lordotic design feature in the oblique plane, allowing surgeons to restore sagittal alignment of the spine while avoiding the introduction of an undesired coronal misalignment.
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