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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[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
ConclusionBone substitutes are a further cost in arthrodesis surgery and suboptimal integration leaves foreign bodies on vertebras. Our experience shows that all pedicle screw instrumentation and bracing after surgery obtain stable correction showing in time a solid arthrodesis with autologous bone only, harvested at local site, without bone substitutes or further bone graft.Graphical abstract
Source: European Spine Journal - Category: Orthopaedics Source Type: research
Rationale: Rod breakage after occipitocervical fusion (OCF) has never been described in a patient who has undergone surgery for basilar invagination (BI) and atlantoaxial dislocation (AAD). Here, we present an unusual but significant case of revision surgery to correct this complication. Patient concerns: A 32-year-old female presented with neck pain, unstable leg motion in walking, and also BI with AAD. Her first surgery was planned to correct these conditions and for fusion at the occipital junction (C3-4) using a screw-rod system. At the 31-month follow-up after her first operation, the patient complained of severe...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
The objective of this retrospective clinical study is to compare the long-term clinical efficacy of posterior long-segment and short-segment fixation with single-stage transpedicular debridement and fusion for the treatment of thoracolumbar spinal tuberculosis in adults.MethodsSixty-six cases of thoracolumbar tuberculosis were treated by single-stage transpedicular debridement, bone graft fusion, and pedicle screw fixation. Thirty-five cases were under long-segment fixation (group A) and 31 cases were under short-segment fixation (group B). These patients were followed up for a minimum of five  years. The clinical and...
Source: International Orthopaedics - Category: Orthopaedics Source Type: research
Conclusion: Similar results were obtained in respect of fusion in all 3 groups. Without the use of additional grafts, sufficient fusion can be achieved with the use of local autograft alone for posterior spinal fusion in patients with AIS. PMID: 29306231 [PubMed - as supplied by publisher]
Source: Turkish Journal of Medical Sciences - Category: General Medicine Tags: Turk J Med Sci Source Type: research
NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for its Cohere cervical interbody fusion device and that it launched the Coalesce thoracolumbar interbody fusion device. Both the launch and updated clearance comes from the company’s acquisition of Vertera Spine, which it closed last September. The Cohere and Coalesce implants use porous version of the material polyetheretherketone, or PEEK, and are designed to provide three-dimensional achitecture to elicit and encourage bone growth, San Diego, Calif.-based NuVasive said. “Our strategy in building our AMS portfolio is to ...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news
Conclusions: Short segment pedicle screw fixation with posterior decompression and interlaminar fusion provided considerable reduction in kyphosis, restored the vertebral height of patients with thoracolumbar vertebral injuries and neurological deficit, and prevented development of delayed kyphotic deformity. PMID: 29279751 [PubMed]
Source: Asian Spine Journal - Category: Orthopaedics Tags: Asian Spine J Source Type: research
Conclusion. Posterior hemivertebra resection with anterior structural reconstruction and short segmental fusion is a reliable procedure for selected patients with scoliokyphosis because of hemivertebra. A structural reconstruction is essential to the avoidance of overcorrection of the segmental scoliosis and resultant postoperative coronal imbalance with limited fused levels in some patients, increasing chances of short segmental fusion and saving mobile segments. As a fulcrum, anterior reconstruction with a titanium mesh cage could help to improve the correction of segmental kyphosis. Furthermore, the cage may help to s...
Source: Spine - Category: Orthopaedics Tags: Deformity Source Type: research
Conclusions: In our series of pediatric patients the incidence of a deep SSI was 2.7%. The only predictor of SSI was the presence of a CTD.
Source: Journal of Pediatric Orthopaedics - Category: Orthopaedics Tags: Infection Source Type: research
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