The Tether™– Vertebral Body Tethering System is a non-fusion spinal device intended for treatment of idiopathic scoliosis.

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Vertebral Body Tethering System Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster, CO 80021 USA +1 800.447.3625 zimmerbiomet.com only DEVICE DESCRIPTION The Tether™ – Vertebral Body Tethering System is a non-fusion spinal device intended for treatment of idiopathic scoliosis.

", FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. Anterolateral tethering been performed via a thoracoscopic spinal approach clinically for a number of years and the early clinical outcomes are beginning to appear in the literature.

Image: Tether device proves that tethering the spinal cord can correct scoliosis (Photo courtesy of FDA). The procedure performed by Baron S. Lonner, MD, Professor of Orthopedic Surgery, and Pediatrics, Icahn School of Medicine at Mount Sinai, and Chief of Minimally Invasive Scoliosis Surgery, Mount Sinai Health System, uses the latest technology that was recently approved by the U.S. Food and Drug Administration (FDA). Mount Sinai surgeons have performed the first-ever spinal tethering surgery to correct idiopathic scoliosis – a sideways curvature in the spine in children and adolescents. Dr. Lonner led in the research and development of the procedure, the first of its kind approved by the FDA for non-fusion scoliosis correction. Approximately 6,800 patients in the U.S. each year will develop progressive curvatures that do not respond to bracing. The FDA reviewed data for The Tether - Vertebral Body Tethering System through the humanitarian device exemption (HDE) process. It is the most common spinal deformity in children and is most often diagnosed between ages 10 to 18, although it may occur at a younger age. Sign up for Healthcare Purchasing News eNewsletters.

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As an alternative to spinal fusion surgery, the device allows motion in the operated segments of the spine. Sitemap. There is also a learning curve for this as for all innovative procedures, and hands-on training courses and mentorship from more experienced surgeons is required in order to maintain the highest level of safety. Researchers at St. Michael’s Hospital... A new study suggests that the use of nitrous oxide (N2O) as a pain relief option for women in labor is safe for both newborn child and mother. “The Tether embodies Zimmer Biomet’s mission to improve the quality of life for people around the world. ", 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. Today's approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis. Zimmer Biomet Spine has shared with the FDA that it will be partnering with the Harms Study Group, a cohort of surgeons dedicated to the advancement of treatment for children and adolescents with spinal deformities, to develop a patient data registry to help assess the long-term performance of The Tether System. The new contraceptive, named Phexxi, a product of Evofem Biosciences (San Diego,... A novel vaginal speculum introduces a major redesign that takes into account both patient experience and unmet clinical needs. 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. Your use of this website constitutes acceptance of Haymarket Media’s Privacy Policy and Terms & Conditions.

The Tether™– Vertebral Body Tethering System is a non-fusion spinal device intended for treatment of idiopathic scoliosis.

We use cookies to enhance your experience.

Vertebral Body Tethering System Zimmer Biomet Spine, Inc. 10225 Westmoor Dr. Westminster, CO 80021 USA +1 800.447.3625 zimmerbiomet.com only DEVICE DESCRIPTION The Tether™ – Vertebral Body Tethering System is a non-fusion spinal device intended for treatment of idiopathic scoliosis.

", FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. Anterolateral tethering been performed via a thoracoscopic spinal approach clinically for a number of years and the early clinical outcomes are beginning to appear in the literature.

Image: Tether device proves that tethering the spinal cord can correct scoliosis (Photo courtesy of FDA). The procedure performed by Baron S. Lonner, MD, Professor of Orthopedic Surgery, and Pediatrics, Icahn School of Medicine at Mount Sinai, and Chief of Minimally Invasive Scoliosis Surgery, Mount Sinai Health System, uses the latest technology that was recently approved by the U.S. Food and Drug Administration (FDA). Mount Sinai surgeons have performed the first-ever spinal tethering surgery to correct idiopathic scoliosis – a sideways curvature in the spine in children and adolescents. Dr. Lonner led in the research and development of the procedure, the first of its kind approved by the FDA for non-fusion scoliosis correction. Approximately 6,800 patients in the U.S. each year will develop progressive curvatures that do not respond to bracing. The FDA reviewed data for The Tether - Vertebral Body Tethering System through the humanitarian device exemption (HDE) process. It is the most common spinal deformity in children and is most often diagnosed between ages 10 to 18, although it may occur at a younger age. Sign up for Healthcare Purchasing News eNewsletters.

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