NuVasive wins expanded FDA nod, launches interbody fusion devices

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 provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants. Our launch of Coalesce and the expanded clearance of Cohere and Coalesce are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life,” chair &CEO Gregory Lucier said in a prepared statement. The company said that the Coalesce device is now available for TLIF and PLIF procedures in multiple footprints, heights and lordotic options. Its indications include use for one or two adjacent levels in the thoracolumbar spine with both autograft and allograft for treating degenerative disc disease and degenerative spondylolisthesis and multi-level degenerative sc...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news

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CONCLUSIONS: A high index of suspicion is needed to diagnose sacral insufficiency fracture after LS arthrodesis. A trial of conservative management is reasonable for select patients; potential surgical indications include refractory pain, neurological deficit, fracture nonunion with anterolisthesis or kyphotic angulation, L5-S1 pseudarthrosis, and spinopelvic malalignment. Lumbopelvic fixation with iliac screws may be effective salvage treatment to allow fracture healing and symptom improvement. High-risk patients may benefit from prophylactic lumbopelvic fixation at the time of index LS arthrodesis. PMID: 32217798 [P...
Source: Journal of Neurosurgery.Spine - Category: Neurosurgery Authors: Tags: J Neurosurg Spine Source Type: research
ConclusionInter-rater reliability for 3 raters, evaluating 177 disc levels, was found to be overall acceptable for 6 out of 8 degenerative MRI-findings in the lumbar spine. Ratings of facet joint degeneration and disc contour achieved moderate reliability and was considered unacceptable.
Source: Chiropractic and Manual Therapies - Category: Complementary Medicine Source Type: research
AbstractBackground Scoliosis with spondylolisthesis was described in 4.4 –48%. No information on clinical impact or outcome is available.PurposeTo determine the prevalence of this pathology and to investigate its affect on the course of adolescent idiopathic scoliosis (AIS).MethodsA retrospective comparative study using patients ’ records, radiographs, the national inpatient registry, and Patient-rated outcome measures (PROM): Oswestry disability index (ODI), modif.SRS-24 questionnaire, WHO-Quality of life index (WHOQoL), Numerical rating scale (NRS) for pain. Clinical follow-up time was 4.4 (4.3) years, and ...
Source: European Spine Journal - Category: Orthopaedics Source Type: research
Few would have predicted that Tiger Woods would be playing in the P.G.A. Championship this week. He had three failed back surgeries, starting in 2014. He had taken opioids. His astonishing career seemed over.Then he had one more operation, a spinal fusion, the most complex of all, in 2017. And last month he won the Masters, playing the way he used to.An outcome like his from fusion surgery is so rare it is"like winning the lottery," Dr. Sohail K. Mirza, a spine surgeon at Dartmouth, said.The idea behind spinal fusion is to remove a disk — a ring of fibers filled with a nerve-cushioning jelly that joins adja...
Source: Psychology of Pain - Category: Anesthesiology Source Type: blogs
Publication date: Available online 10 May 2019Source: Journal of Clinical NeuroscienceAuthor(s): Xu Zhengkuan, Chen Qixin, Chen Gang, Li FangcaiAbstractThe aim of this study was to demonstrate the techniques of modified lateral lumbar interbody fusion and investigate its approach related complications. Fifty-two patients underwent with modified lateral lumbar interbody fusion (LLIF) in our center were studied retrospectively. There were 20 males and 32 females, aged from 45 to 82 years old (averaged at 66.0 ± 11.2). The diagnosis was as following: degenerative spinal scoliosis in 21 cases, lumbar spinal stenos...
Source: Journal of Clinical Neuroscience - Category: Neuroscience Source Type: research
ConclusionLSS is frequent in lumbar scoliosis. Relationships exist between curve characteristics and symptomatic LSS in lumbar scoliosis; especially, concavity of the lumbosacral contra-curve and the junctional level between the lumbar curve and the lumbosacral contra-curve. Therefore, accurate analysis of stenosis in ASD seems mandatory, to at least perform decompression because perfect planned treatment for stenosis and scoliosis correction might not always be possible because of the patient's general health status.Level of EvidenceLevel 4.
Source: Spine Deformity - Category: Orthopaedics Source Type: research
Authors: Campos M, Vial R, Castro J, Urrutia J Abstract High-intensity zone is an area of high-intensity signal within the posterior annulus fibrosus observed in magnetic resonance imaging; initially described in painful discs, recent studies have described similar prevalence in symptomatic and asymptomatic subjects. Since its' prevalence in the general population has not been established, we used a screening tool independent of spinal symptoms to determine high-intensity zone prevalence. We studied 217 patients evaluated with abdominal-pelvic magnetic resonance imaging; we looked for high-intensity zone, disc dege...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
This study aimed to obtain reference values of lumbar lordosis (LL) and lower LL (LLL) from normal asymptomatic groups, determine the relationship between them and pelvic incidence (PI), and establish the predictive formula for ideal LLL in the elderly Korean population.MethodsStanding plain lateral radiographs of the whole spine, including the pelvis, were analyzed in asymptomatic adult male volunteers without back pain or prior surgery involving the spine or lower extremity. Volunteers with scoliosis, spondylolisthesis, segmental disk space narrowing, and/or compression fractures in the radiographs were excluded. The fol...
Source: European Spine Journal - Category: Orthopaedics Source Type: research
Conclusion. While the prevalence of spinal pathologies is not known, the rate of elective lumbar fusion surgery in the United States increased most for spondylolisthesis and scoliosis, indications with relatively good evidence of effectiveness. The proportion of fusions coded for indications with less evidence of effectiveness has slightly decreased in the most recent years. Level of Evidence: 3
Source: Spine - Category: Orthopaedics Tags: SURGERY Source Type: research
ConclusionsIn situ fusion for high-grade isthmic spondylolisthesis is a safe treatment option in the long term from a function and pain perspective, but the results of our study suggest that self-image is negatively affected long into adult life.Level of EvidenceLevel IV.
Source: Spine Deformity - Category: Orthopaedics Source Type: research
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