CHOP is on the forefront of this technology, having received approval from the FDA to conduct a trial on vertebral tethering prior to … Today's approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis. "FDA regulatory status through the HDE pathway may give more surgeons the impetus to learn the best indications, learn the how-to of the approaches for tethering, and then begin to progress through the learning curve utilizing cadaver courses, hands-on simulations, surgeon visitation and tackling simpler cases early on, such as ones in which fewer instrumented segments are required for smaller and more flexible curves as opposed to larger, more rigid deformities which are more challenging. Researchers at the University of Michigan (U-M; Ann Arbor,... A compact counter-top ultraviolet C (UVC) unit quickly and effectively disinfects any objects placed inside it. The Food and Drug Administration (FDA) has approved a unique device for pediatric patients with idiopathic scoliosis who have not responded to conservative treatment options. If the curves are not adequately corrected by the system, spinal fusion surgery is still possible. Patients may resume activities including bending, lifting, and twisting, as soon as six weeks following tethering, and can pursue the highest level of athletics, dance, and gymnastics virtually unimpeded, while recovery following a spinal fusion could take 12 weeks and may result in limitations in some activities. In this interview, Dr. Gina Poe speaks to News-Medical about why we sleep, and the importance of REM sleep for brain development. Owned and operated by AZoNetwork, © 2000-2020. Copyright © 2020 Haymarket Media, Inc. All Rights Reserved My team and I have extensive experience in performing vertebral body tethering (VBT) at our center. For those patients whose curves are not adequately corrected by The Tether - Vertebral Body Tethering System, spinal fusion surgery is still possible. This site uses Akismet to reduce spam. For these patients, spinal fusion surgery can be used to permanently stabilize and correct spinal curvatures. An innovative spinal tether device corrects idiopathic scoliosis in children and adolescents who fail to respond to conservative treatment options, such as external bracing. Get the latest news and education delivered to your inbox, Receive an email when new articles are posted on, Please provide your email address to receive an email when new articles are posted on, Chief of minimally invasive scoliosis surgery, Tell us what you think about
The Capsa Healthcare (Portland, OR, USA) Trio mobile workstation is designed... Translumbosacral neuromodulation therapy (TNT) of nerves that regulate muscles in the anus and rectum dramatically reduce episodes of fecal incontinence (FI), according to a new study. The FDA reviewed clinical data supporting the safety and probable benefit of The Tether - Vertebral Body Tethering System from 57 patients who received the device. Researchers at the University of California Davis (UCD;... Extracorporeal membrane oxygenation (ECMO) reduces mortality in critically ill COVID-19 patients to less than 49%, according to a new study. The FDA has approved the first spinal tether device intended to be used in children and adolescents, who have not responded to conservative treatment options, such as external bracing, to correct idiopathic scoliosis. The device, called The Tether - Vertebral Body Tethering System, is intended to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option. Researchers at King’s College London (KCL; United Kingdom),... An artificial intelligence (AI) based software assists radiologists in reading screening mammograms for breast cancer detection. Initial results of anterolateral tethering in growing patients with spinal deformities are encouraging, however the results 3–4 years after the procedure are somewhat mixed. Stratus Medical has received a pair of U.S. patents for its Nimbus RF Multitined Expandable Electrode. The Zimmer Biomet Spine device, called The Tether—Vertebral Body Tethering System, is intended, according to an August 16, 2019 FDA announcement, "to treat growing children and adolescents whose spinal curves are approaching or have reached the range where surgical treatment is an option." 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. A flexible cord, the tether, is connected to the screws. An innovative spinal tether device corrects idiopathic scoliosis in children and adolescents who fail to respond to conservative treatment options, such as external bracing. Unlike spinal fusion, VBT is a reversible procedure, and there is potential for less adjacent segment disc degeneration compared to spinal fusion, which will be determined only with long-term follow-up. Image: Tether device proves that tethering the spinal cord can correct scoliosis (Photo courtesy of FDA). But the Zimmer Biomet system, according to the agency, is designed to continue to correct the curvature while maintaining a fuller range of motion. The FDA reviewed clinical data from 57 patients who received the device. Tension is applied to the tether during surgery to compress one side of the spine and to partially correct the curve. HIPAA allegations cost Athens Orthopedics $1.5 million due to a 2016 cybersecurity breach. “Today’s approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis.”. “For children and adolescent patients with idiopathic scoliosis that does not respond favorably to bracing, treatment options have been limited to fusion surgeries,” Capt. You’ve read {{metering-count}} of {{metering-total}} articles this month. ", The company statement from Zimmer Biomet said this approval "marks the culmination of more than five years of cooperation between the FDA and Zimmer Biomet to bring innovative pediatric solutions to market and represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years. Researchers... An advanced thermal screening system measures body temperature from a distance and uses artificial intelligence (AI) to pinpoint people in heavily populated environments with abnormal temperatures.... A new robotic system performs nasal swab tests on its own, helping to prevent cross infections among people being examined. Health care professionals will monitor patients, conducting follow-up x-rays, to track the spinal curvature and identify any potential problems that might require additional surgery to revise or remove the device. In this interview, News-Medical speaks to researchers about their latest research which could reveal the secret to eternal youth, fecal transplants. How does the COVID-19 Pandemic Compare to Other Pandemics? The FDA reviewed data for the system through the humanitarian device exemption (HDE) process. According to the FDA, at two years, 43 patients had sufficient improvement of the curvature of their spines and did not need spinal fusion. This provides additional correction of the curve as the patient continues to grow. “For children and adolescent patients with idiopathic scoliosis that does not respond favorably to bracing, treatment options have been limited to fusion surgeries,” said Capt. Sitemap. Tension is then applied to a flexible cord that is connected to the screws during surgery which compresses one side of the spine and partially corrects the curve; the cord continues to straighten the spine while the patient continues to grow. Personally, my team and I progressed through the learning curve and optimized our techniques beginning 25 years ago with minimally invasive, thoracoscopic approaches for spinal fusion for thoracic and thoracolumbar scoliosis which are the same approaches used to perform tethering. The Quantum Innovations (Central Point, OR, USA) FusionUV, unlike other germicidal UV... A new non-hormonal gel prevents contraception by keeping vaginal pH levels in a range that is inhospitable to sperm.
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