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

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Abstract Aneurysmal bone cysts (ABCs) rarely trigger pathological fractures. Various surgical and nonsurgical treatments have been reported for this condition. Herein, we present the examination findings and treatment for a 15-year-old girl who initially presented with adolescent idiopathic scoliosis and mild back pain, but subsequently experienced severe back pain. Magnetic resonance imaging revealed an ABC at T1, with an associated pathological fracture. We successfully treated the patient using posterior fixation with instrumentation, curettage, and bone grafts combined with calcitonin and methylprednisolone (m...
Source: Journal of Orthopaedic Surgery - Category: Orthopaedics Authors: Tags: J Orthop Surg (Hong Kong) Source Type: research
The anterior and middle columns instead of the posterior column of spine are usually destroyed by tuberculosis which could aggravate the kyphosis accompanying the growth imbalance of spine in children. The surgical method needs to be selected cautiously for effective treatment. To our knowledge, few studies have evaluated mid-term outcomes of 2 surgeries (posterior-only approach and combined posterior and anterior approaches) with allograft or shaped titanium mesh cages for the treatment of lumbar tuberculosis in children. The study aims to compare the surgical mid-term outcomes of the posterior-only approach and the combi...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
AbstractObjectiveThe purpose of this study was to evaluate its effect on the restoration and maintenance of cervical sagittal alignment in usual cervical degenerative diseases without preoperative sagittal malalignment.Materials and methodsWe retrospectively evaluated 108 patients who were diagnosed with degenerative cervical disease and underwent ACDF (allograft and plating) with  >  1-year follow-up. For radiographic evaluation, we analysed segmental and C2–7 cervical lordosis, disc height, C2–7 sagittal vertical axis (SVA), T1 slope, and T1 slope minus C2–7 lordosis (T1S −...
Source: European Journal of Orthopaedic Surgery and Traumatology - Category: Orthopaedics Source Type: research
ConclusionsLumbar vertebra provided more bone graft than thoracic vertebra. Spinous processes contributed the highest amount of local bone graft in the thoracic and lumbar spine.
Source: Journal of Orthopaedics - Category: Orthopaedics Source Type: research
To investigate the clinical efficacy of surgical treatment for thoracic spinal tuberculosis with kyphosis deformity via posterolateral debridement, fusion, posterior instrumentation and local continuous chemotherapy. A total of 25 patients with thoracic tuberculosis received surgery by posterolateral decompression, fusion, posterior instrumentation, and postural drainage with local continuous chemotherapy between June 2009 and October 2011. The clinical outcomes was evaluated using statistical analysis about deformity correction, bone fusion, neurologic status, and the visual analog score (VAS) and erythrocyte sedimentatio...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
Conclusions: In ACDF with plate fixation, cortical ring allograft filled with DBM group showed similar radiological and clinical outcomes compared with those of the autograft group. If the metal plate is reinforced, using cortical ring allograft could be a viable alternative to autograft. PMID: 30472821 [PubMed - as supplied by publisher]
Source: Asian Spine Journal - Category: Orthopaedics Tags: Asian Spine J Source Type: research
NuVasive (NSDQ:NUVA) said today it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures. The San Diego-based company touted that its porous PEEK technology offers both three-dimensional architecture and the radiolucent properties of PEEK, which it claims provides “increased clarity in postoperative x-rays and imaging.” “Cohere XLIF with its one-of-a-kind Porous PEEK technology provides surgeons the best implant for treating patients. It is designed to allow early incorporation of bone into the inter-body spacer, whic...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news
AbstractPurposeTo evaluate the influence of anterior fusion option on the short- and long-time outcomes on multilevel spinal reconstructions in young children.MethodsForty-five patients aged under 4  years old (2 years 2 months ± 11 months in average) underwent spinal reconstruction due to tuberculosis spondylitis (35), pyogenic spondylitis (9) and spinal tumors (1) complicated by angular kyphosis exceeded 20° (49.2° ± 14.3° in average). All lesions involved two or more spinal motion segments. Clinical and radiographic data were compared in two group...
Source: European Spine Journal - Category: Orthopaedics Source Type: research
[Image from unsplash.com]From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press release that it has received FDA clearance for its wireless LP1100 Life Signal Patch. The patch is designed to be used in wearables and healthcare monitoring devices. The clearance allows the company to use the Life Signal Processor to develop ECG and other vital sign monitoring wearables ...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Diagnostics Food & Drug Administration (FDA) Hospital Care Imaging Patient Monitoring Prosthetics Regulatory/Compliance DoseOptics FBC Device Flashback Technologies Health.io LifeSignal Medi-Lynx Cardiac Monitoring MedTe Source Type: news
ANZ Journal of Surgery, EarlyView.
Source: ANZ Journal of Surgery - Category: Surgery Authors: Source Type: research
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