FDA Approval 'Finally ' Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment

A first-of-its-kind FDA approval represents a major win for Zimmer Biomet and, most importantly, the field of scoliosis treatment. Called The Tether – Vertebral Body Tethering System, the device is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option. It is intended to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. “This decision takes an innovative surgical approach, vertebral body tethering, and finally recognizes it as a mainstream option for scoliosis treatment,” said Baron Lonner, MD, chief of minimally invasive scoliosis surgery at The Mount Sinai Health System. “This FDA approval sets the stage for better patient outcomes for thousands of children who undergo surgery for scoliosis around the country every year.” Lonner, a world-leading scoliosis specialist, is among the few surgeons performing vertebral body tethering (VBT) in the United States prior to this approval. He has performed VBT more than 220 times. Prior to this approval, these specialists were repurposing an implant that was initially approved for use in adult lumbar procedures, slightly modifying the implant for use in the pediatric population. The benefits of VBT led to growing demand ...
Source: MDDI - Category: Medical Devices Authors: Tags: Orthopedics Implants Source Type: news

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We describe the most highly recommended generic and disease-specific PRO tools in SCD and discuss the challenges of incorporating them in clinical practice. EXPERT OPINION: PRO measures are essential to incorporate into SCD clinical trials either as primary or secondary outcomes. The use of PRO measures in SCD facilitates a patient-centered approach, which is likely to lead to improved outcomes. Significant challenges remain in adapting PRO tools to routine clinical use and in developing countries. PMID: 33034214 [PubMed - as supplied by publisher]
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
Publication date: Available online 10 October 2020Source: Meta GeneAuthor(s): Mansour Zamanpoor, Hamid Ghaedi, Mir Davood Omrani
Source: Meta Gene - Category: Genetics & Stem Cells Source Type: research
Currently in fellowship doing bread/butter procedures (MBB, epidurals, PNB, few SCS/PNS trials, etc.) and just interviewed at a private practice spot where they do a lot of procedures that I will have not done any training in prior to graduating (e.g. IT pump, SI fusion, Vertiflex, Kypho, MILD, Discectomy, lots of SCS/PNS trials etc) and significant amount of "OR pain procedures" at a very busy practice seeing 30-40 pts/day - how many of you are commonly performing these procedures and are... private practice concern
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
Authors: Zhao N, Xiang Q, Liu Z, Zhao X, Cui Y Abstract INTRODUCTION: There remains an unmet need for better anticoagulants. The phase I clinical trial is of great significance in the development of anticoagulants, and the design is special. This system review aims to provide insights for the design of future phase I clinical trials of anticoagulants. AREAS COVERED: We searched the database PubMed and ClinicalTrail.gov website, to collate the phase I clinical trial of anticoagulants in healthy people. The study protocol, inclusion exclusion criteria, safety and pharmacodynamic indexes were reviewed. EXPERT ...
Source: Expert Review of Clinical Pharmacology - Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research
Abstract Trace metals concentrations of 25 elements were determined for 22 subcomponents of biodegradable and non-biodegradable waste samples representing the United States municipal solid waste (MSW) stream collected during three separate waste sorts. The subcomponent trace metal concentrations and estimated composition results were used to predict trace metal concentrations present in the overall MSW stream along with MSW compost and waste to energy (WTE) ash, which were compared to health-based standards (i.e., US EPA regional screening levels) and to values previously reported in the literature. These estimate...
Source: Chemosphere - Category: Chemistry Authors: Tags: Chemosphere Source Type: research
Publication date: October 2020Source: Brain, Behavior, and Immunity, Volume 89Author(s): Fernando Lopes, Fernando A. Vicentini, Nina L. Cluny, Alexander J. Mathews, Benjamin H. Lee, Wagdi A. Almishri, Lateece Griffin, William Gonçalves, Vanessa Pinho, Derek M. McKay, Simon A. Hirota, Mark G. Swain, Quentin J. Pittman, Keith A. Sharkey
Source: Brain, Behavior, and Immunity - Category: Neurology Source Type: research
BEST supplements to relieve joint pain: Is your arthritis playing up? The wetter and colder months could partially be to blame. These two pills may help.
Source: Daily Express - Health - Category: Consumer Health News Source Type: news
Authors: Kim H, Lim YM, Lee EJ, Kim HW, Ahn HS, Kim KK PMID: 33029979 [PubMed]
Source: Journal of Clinical Neurology - Category: Neurology Tags: J Clin Neurol Source Type: research
CONCLUSIONS: More than half of the iIONP patients had an enhanced oculomotor nerve in MRI. A few of them also had elevated CSF IgG synthesis rate, but no further evidence for inflammation was found. The administration of steroids seemed to have no benefit other than increasing the blood glucose level. PMID: 33029972 [PubMed]
Source: Journal of Clinical Neurology - Category: Neurology Tags: J Clin Neurol Source Type: research
Authors: Fentie K, Wakayo T, Gizaw G Abstract Background: Anemia defined as a low blood hemoglobin concentration is public health importance. The adolescence age group is the most neglected in public health and nutrition research as priorities are usually given to pregnant women, lactating mothers, and their children less than 2 years. Current Ethiopian Food and Nutrition policy included adolescent girls in the most at-risk group for nutritional demands; however, only a few published studies have assessed a deficiency of anemia and associated factors to tackle the intergenerational cycle of malnutrition. Object...
Source: Anemia - Category: Hematology Tags: Anemia Source Type: research
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