Cervical vertebral body replacement system made from PEEK-Optima HA receives FDA 510(k) clearance

Omnia Medical (Morgantown, WV) has been granted the first FDA 510(k) clearance for a cervical vertebral body replacement (VBR) system manufactured from PEEK-Optima HA Enhanced polymer from Invibio Biomaterial Solutions (Thornton Cleveleys, UK). The so-called Boxcar system is designed for use in cervical-corpectomy procedures, the replacement of a collapsed, damaged or unstable vertebral body located in the cervical spine. Robert Gewirtz, a neurosurgeon based in Columbus, OH, collaborated on the development of the Boxcar VBR product. “I see many patients that require a cervical corpectomy, and it's exciting to have such an innovative option for these patients,” he said. “Boxcar is very easy to use and provides intra-operative flexibility, allowing me to dial in a VBR construct to match my patient’s anatomy. Hydroxyapatite is incorporated into the PEEK-Optima structure of the implant, which delivers potentially improved outcomes for my patients,” added Gewirtz. The novel single-use device is available in two footprints and allows fine adjustments of height and lordosis (the inward curvature of the spine) using spacers and end plates. It features a hollow center and holes to accommodate autograft or allograft, while encouraging the formation of new bone, and includes anti-migration features, noted Invibio. "There are a limited number of 510(k) FDA cleared cervical VBR products on the m...
Source: MDDI - Category: Medical Devices Tags: Plastics Today Source Type: news

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The objective of this review is to compare outcomes between multiple augmentation techniques and ongoing discussions of effectiveness of vertebral augmentation procedures.Recent FindingsVertebral compression fractures (VCFs) are a prevalent disease affecting approximately 1.5 million US adults annually. VCFs can cause severe physical limitations, including back pain, functional disability, and progressive kyphosis of the thoracic spine that ultimately results in decreased appetite, poor nutrition, impaired pulmonary function, and spinal cord compression with motor and sensory deficits. The deconditioning that affects patie...
Source: Current Pain and Headache Reports - Category: Neurology Source Type: research
Discussion. Preoperative assessment and analyzing the progression of pain in the acute postoperative period can help identify those at risk of negative long-term outcomes after surgery. PMID: 32184913 [PubMed - in process]
Source: Pain Research and Management - Category: Anesthesiology Authors: Tags: Pain Res Manag Source Type: research
ConclusionMost interventions for ASD improve patients ’ complaints but do not totally eliminate them. Reporting the percentage achieving a score equivalent to an “acceptable state” may represent a more stringent and discerning target for denoting treatment success in ASD.Graphic abstract These slides can be retrieved under Electronic Supplementary Material.
Source: European Spine Journal - Category: Orthopaedics Source Type: research
Authors: Hey HWD, Ng NL, Loh KYS, Tan YH, Tan KA, Moorthy V, Lau ETC, Liu G, Wong HK Abstract Study Design: Prospective radiographic comparative study. Purpose: To compare and understand the load-bearing properties of each functional spinal unit (FSU) using three commonly assumed, physiological, spinal postures, namely, the flexed (slump sitting), erect (standing) and extended (backward bending) postures. Overview of Literature: Sagittal spinal alignment is posture-dependent and influences the load-bearing properties of the spine. The routine placement of intervertebral cages "as anterior as possible&q...
Source: Asian Spine Journal - Category: Orthopaedics Tags: Asian Spine J Source Type: research
Study Design. Retrospective review of a prospective database. Objective. The aim of this study was to evaluate postop clinical recovery among adult spinal deformity (ASD) patients between frailty states undergoing primary procedures Summary of Background Data. Frailty severity may be an important determinant for impaired recovery after corrective surgery. Methods. It included ASD patients with health-related quality of life (HRQLs) at baseline (BL), 1 year (1Y), and 3 years (3Y). Patients stratified by frailty by ASD-frailty index scale 0-1(no frailty: 0.5 [SF]). Demographics, alignment, and SRS-Schwab modifiers...
Source: Spine - Category: Orthopaedics Tags: DEFORMITY Source Type: research
This study aimed to elucidate the short-term outcome of the antSS+LP procedure. METHODS: The authors' analysis was based on data from 14 patients who underwent antSS+LP for cervical myelopathy caused by massive OPLL and were followed up for at least 2 years after surgery (mean follow-up duration 3.3 years). Clinical outcome was evaluated preoperatively, at 6 months and 1 year postoperatively, and at the final follow-up using the Japanese Orthopaedic Association (JOA) scoring system for cervical myelopathy and the recovery rate of the JOA score. The following radiographic parameters were measured preoperatively, immedi...
Source: Journal of Neurosurgery.Spine - Category: Neurosurgery Authors: Tags: J Neurosurg Spine Source Type: research
AbstractWhile open surgery has been the primary surgical approach for adult degenerative scoliosis, minimally invasive surgery (MIS) represents an alternative option and appears to be associated with reduced morbidity. Given the lack of consensus, we aimed to conduct a systematic review on available literature comparing MIS versus open surgery for adult degenerative scoliosis. PubMed, Embase, and Cochrane databases were searched through December 16, 2019, for studies that compared both MIS and open surgery in patients with degenerative scoliosis. Four cohort studies reporting on 350 patients met the inclusion criteria. In ...
Source: Neurosurgical Review - Category: Neurosurgery Source Type: research
Conclusions: Our study demonstrates that with careful preoperative evaluation, most patients with a spinal cord syrinx can safely be given IM. Certain patients, such as those with a spinal holocord syrinx may have anatomic reasons to avoid IM, but those who are deemed appropriate for IM can receive it safely. Level of Evidence: Level III—therapeutic study; retrospective comparative study.
Source: Journal of Pediatric Orthopaedics - Category: Orthopaedics Tags: Online Articles: Scoliosis Source Type: research
ConclusionModerate and severe grades of VD are identifiable on FR as long as the involved vertebrae are clearly filmed.
Source: Archives of Orthopaedic and Trauma Surgery - Category: Orthopaedics Source Type: research
Conclusion: PVP and PKP could be used in treating KD patients, and the surgical selection could be dependent on the clinical stages and status of postural correction. PMID: 32125194 [PubMed - as supplied by publisher]
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
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