The USFDA approval is granted to the Tether-Vertebral Body Tethering system. The intention of non-fusion spinal device known as Tether™ - Vertebral Body Tethering System is to treat idiopathic scoliosis. It is an abnormal curvature in the spine that occurs without a known cause, in young patients whose bones have not fully matured.
An anchor and bone screw is placed into the patient's spine on the side of the spinal curvature and rod is secured to the bone screws using set screws. Tension is applied to the cord to partially straighten the spine of patient during surgery. After surgery, straightening of the spine continues while the patient continues to grow.
The indication of product is for skeletally immature patients that need surgical treatment to acquire 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.
The product should not be used in patients who have any type of infection; had previous spinal surgeries; malleable bone; issues regarding flow of blood or any allergies with the material of implant.
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