FDA expands indication for NuVasive ’ s TLX spine implant

NuVasive Inc. (NSDQ:NUVA) said today the it won expanded 510(k) clearance from the FDA for its TLX implant used in spinal fusion surgery. San Diego-based NuVasive said the new clearance covers an new, expandable 20° cage and new indications for use covering allogeneic bone grafts and more spine levels. “With the additional clearance for our latest TLX system, we now provide the leading tools for [transforaminal lumbar interbody fusion] procedures with our MAS TLIF solution, validating our commitment to improving spine solutions,” strategy, technology & corporate development EVP Matt Link said in prepared remarks. “This clearance highlights our persistent investment in transforming spine outcomes by developing spine’s leading procedures, materials, expandables, systems and services.” “The procedurally-integrated TLIF platform from NuVasive has allowed me to become much more efficient in my TLIF procedures,” added Dr. William Hunter of the Neuroscience & Spine Center of the Carolinas. “The platform also allows me to confirm restoration of my patients’ lordosis intra-operatively using NuvaMap O.R. These tools have made my procedures more predictable, providing optimal treatment for my patients.” The post FDA expands indication for NuVasive’s TLX spine implant appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Spinal Nuvasive Source Type: news