Humanitarian Device:
Authorized by Federal law for use in the treatment of skeletally immature patients that 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. Patients should have failed bracing and or be intolerant to brace wear. The effectiveness of this device for this use has not been demonstrated.
Indications For Use
The Tether™ - Vertebral Body Tethering System is indicated for skeletally immature patients that 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. Patients should have failed bracing and/or be intolerant to brace wear.
Contraindications
The Tether™ - Vertebral Body Tethering System should not be implanted in patients with the following conditions:
- Presence of any systemic infection, local infection, or skin compromise at the surgical site;
- Prior spinal surgery at the level(s) to be treated;
- Known poor bone quality defined as a T-score -1.5 or less;
- Skeletal maturity;
- Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patients unwillingness or inability to cooperate with post-operative care instructions.