NuVasive wins FDA nod for Cohere XLIF implant components

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, which may lead to the prevention of expulsion and promotion of early fusion which allows a quicker and better way back to an active lifestyle for my patients. Incorporating Cohere Porous PEEK implants into XLIF procedures keeps imaging characteristics that we all love about PEEK implants intact. Cohere XLIF takes the gold standard of lateral interbody fusion and raises the bar, allowing our patients to receive the best surgery with the best implant possible,” Duke Health orthopedic spine surgeon Dr. Christopher Brown said in a press release. With the clearance, Cohere implants can be used with autograft and/or allograft in skeletally mature patients for thoracolumbar pathologies that include degenerative disc disease, degenerative spondylolisthesis and degenerative scoliosis, NuVasive said. “It’s exciting to extend our patented interbody t...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Nuvasive Source Type: news

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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
Abstract OBJECTIVEThe management of lumbar spinal stenosis (LSS) with concurrent scoliosis and/or spondylolisthesis remains controversial. Full-endoscopic unilateral laminotomy for bilateral decompression (ULBD) facilitates neural decompression while preserving stabilizing osseoligamentous structures and may be uniquely suited for the treatment of LSS with concurrent mild to moderate degenerative deformity. The safety and efficacy of full-endoscopic versus minimally invasive surgery (MIS) ULBD in this patient population is studied here for the first time.METHODSA retrospective analysis of prospectively collected d...
Source: Neurosurgical Focus - Category: Neurosurgery Authors: Tags: Neurosurg Focus 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. The rate of LSS surgery more than tripled in Norway from 1999 to 2013. The mean length of hospital stay was reduced from 11 to 5 days. Level of Evidence: N/A
Source: Spine - Category: Orthopaedics Tags: SURGERY 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
Publication date: March 2019Source: Spine Deformity, Volume 7, Issue 2Author(s): Subaraman Ramchandran, Stephen George, Jahangir Asghar, Harry ShufflebargerAbstractStudy DesignSingle-center retrospective study.ObjectiveTo analyze two-year postoperative outcomes following spinopelvic fixation in pediatric patients using the anatomic trajectory (AT) portal for iliac screws.SummaryIliac fixation is crucial in situations requiring fusion to sacrum. Challenges include complex anatomy, pelvic deformation, severe deformity, and previous surgery. The PSIS portal requires significant dissection, rod connectors, and complex bends. T...
Source: Spine Deformity - Category: Orthopaedics Source Type: research
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