Ahead of The Curve – Tether a Caregiver’s storyOctober 25, 2021
“Ahead of the Curve”
Ghost Productions produced story driven character animation tells the story of Tara’s mother and her research on different treatment options for scoliosis and finding Zimmer Biomet’s vertebral body tethering device The Tether.
Zimmer Biomet’s Innovative Treatment for Young Patients with Scoliosis Receives FDA Approval
The Tether™ represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years
As an emerging treatment for a select patient population, The Tether is available through the FDA’s humanitarian device exemption (HDE) pathway. 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. Considering the recent removal (per FDA final rule) of many semi-rigid stabilization systems that were historically used for AVBT, this solution arrives at a critical time for continuation of care.
“The Tether embodies Zimmer Biomet’s mission to improve the quality of life for people around the world. This collaboration demonstrates how a focused, shared purpose can fundamentally change the way we approach treatment of diseases like scoliosis,” said Jim Cloar, President of Zimmer Biomet Spine. “Working together, clinicians, the FDA and Zimmer Biomet have given surgeons an important fusion-less scoliosis treatment option for their pediatric patients. This procedure gives kids the best option for maintaining spine mobility and reaching their full potential.”
Collaboration will continue as Zimmer Biomet and the FDA finalize a new clinical study for The Tether to optimally monitor patient outcomes. For the new study, Zimmer Biomet is excited to partner with the Harms Study Group, a worldwide cohort of surgeons with over 20 years of productivity who perform comprehensive, multi-center, prospective research studies focused on pediatric spinal deformity.
About The Tether – Vertebral Body Tethering System
The Tether is a non-fusion spinal device intended for use as a spinal tether. An anchor and bone screw are placed from a lateral approach into the spine on the convex side of a spinal deformity. A cord is secured to the bone screws with set screws to connect the levels of the construct, providing a lateral tension band to the spine that can arrest or correct the deformity. The Tether – Vertebral Body Tethering System is designed to treat skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. To be selected for this treatment, patients should have failed bracing and/or be intolerant to brace wear.
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