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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Authors: Smith EJ, Inkrott BP, Kim CY, Du JY, Ahn UM, Ahn NU Abstract The prevalence of obesity has been rising, creating a major public health concern. While several studies have shown obesity to increase the risk of surgical complications, few have analyzed its effects on reoperation, specifically after singlelevel lumbar discectomy. Data was obtained using the commercially available Explorys software that houses deidentified data for several major healthcare systems. A database search was used to find all patients who had undergone a lumbar discectomy. Scoliosis, spondylolisthesis, smoking history and depression...
Source: Journal of surgical orthopaedic advances - Category: Orthopaedics Tags: J Surg Orthop Adv Source Type: research
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
CONCLUSIONS: Mini-open anterolateral interbody fusion at the L5 S1 level is safe and results in fusion at the same rate as anterior interbody fusion. Most acute complications are minor and resolve spontaneously. PMID: 32197973 [PubMed - as supplied by publisher]
Source: Neurochirurgie - Category: Neurosurgery Tags: Neurochirurgie 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
Conclusion. Postoperative epidural hematoma and excessive or insufficient decompression were often observed in the initial series of patients as the causes for reoperations. We think that it is important to be aware of and prevent such potential problems in any initial series of patients, as there are limitations to any surgical indications for the use of microendoscopic decompression for degenerative segmental scoliosis because of original traction and/or kinking of nerve roots. Level of Evidence: 4
Source: Spine - Category: Orthopaedics Tags: SURGERY Source Type: research
ConclusionThis is the first study to propose an etiology-based classification scheme of ASDz following lumbar spine fusion. This simple classification system may allow for the grouping and standardization of patients with similar pathologies and thus for more specific pre-operative diagnoses, personalized treatments, and improved outcome analyses.
Source: HSS Journal - Category: Orthopaedics Source Type: research
Background: Lumbar herniated nucleus pulposis (HNP) occurs infrequently in the pediatric/adolescent population. A minority of patients with radicular symptoms fail to improve with conservative management and require discectomy. The authors hypothesize that children who ultimately require surgical intervention have an underlying lumbar stenosis predisposing them to continued symptoms. Methods: Pediatric patients with a lumbar HNP on advanced imaging were retrospectively identified at a tertiary pediatric orthopaedic institution. Patients with spondylolisthesis, fractures, previous spine surgery, or structural thoracolu...
Source: Journal of Pediatric Orthopaedics - Category: Orthopaedics Tags: Selected Topics Source Type: research
Spinal fusion is the standard surgical care for numerous pathologic conditions of the spine, including degenerative disc disease, spondylolisthesis, scoliosis, instability of the spine and spinal fractures. Poly(ether ether ketone) (PEEK), due to its properties of artifact free imaging, radiolucency, and an elastic modulus similar to cortical bone, has been the material of choice for interbody implants. While these advantages arise from the physical and mechanical properties of PEEK, its inert, hydrophobic surface and lack of functional groups which promote cell attachment and growth create the potential for poor surgical outcomes.
Source: The Spine Journal - Category: Orthopaedics Authors: 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
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