For some young teens coping with scoliosis (curvature of the spine), there is a promising new alternative to spinal fusion procedures. The Tether™, developed by the medical staff at Shriners Hospitals for Children — Philadelphia, recently received approval from the Food and Drug Administration (FDA) as the first commercially available product specifically for anterior vertebral body tethering (VBT), an innovative surgical procedure that both corrects the curve and maintains flexibility in the spine. The Tether uses patented methods and techniques, and is an exciting new option for certain patients with scoliosis who are still growing and for whom surgery is indicated.
How it works
Instead of using metal rods, VBT uses a strong, flexible cord to gently pull on the outside of a scoliosis curve to straighten the spine. A screw is placed in each vertebra of the curve and then attached to the flexible cord with the spine in a straighter position. Scoliosis progression is stopped, the spine is realigned and can continue to grow, and flexibility is maintained. As the child grows, it is anticipated that curve progression will be halted, and the spine will remain straight. The Tether straightens the spine using the patient’s growth process. The pressure from the cord slows the growth on the tall side of the vertebra, so that the short side can grow and catch up. This novel technology allows for both correction and continued motion at the levels of the spine treated, unlike fusion surgeries. As an emerging treatment for a small patient population, this system is being made available through the FDA’s humanitarian device exemption (HDE) pathway.
An innovative approach
The Philadelphia Shriners Hospital medical staff developed the methods and techniques underlying VBT and has worked closely with the FDA and industry partners to bring this treatment to approval. Because of Shriners Hospitals for Children and the leadership of Amer Samdani, M.D., chief of surgery at Shriners Hospitals for Children — Philadelphia, our health care system has a patent on the new device designed specifically for VBT surgeries. “The ability to utilize a child’s growth to correct the curve in their back is a leap in the way these children are treated – properly selected patients can achieve curve correction while maintaining mobility,” said Dr. Samdani.
A patient perspective
Danika and her parents first came to see Dr. Samdani in August 2018 to discuss options for treating Danika’s scoliosis. As the conversations continued, her spinal curve increased to 41 degrees. Although surgeons at the hospital had completed more than 450 similar procedures using other devices, in September 2019, Danika became the first patient of the Philadelphia Shriners Hospital to have VBT surgery post-FDA clearance of the new, procedure-specific technology. If Danika could say anything to her pre-surgery self about the treatment decision, it would be: “It is worth it.” Shriners Hospitals for Children is committed to offering our patients high quality, compassionate care, and the most innovative treatment options so they have the best chance for a full recovery.