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news News Friday, August 30, 2019 Friday, August 30, 2019 2:27 PM - Friday, August 30, 2019 2:27 PM

New medical device for scoliosis treatment approved by FDA

Portland Shriners Hospital is one of the few hospitals with staff trained to perform innovative scoliosis treatment

New medical device for scoliosis treatment approved by FDA

A new medical device for treating scoliosis – curvature of the spine – has received FDA approval, providing an alternative that both corrects the curve and maintains flexibility in the spine.

Children worldwide are affected by scoliosis, and Shriners Hospitals for Children — Portland has an extensive scoliosis program designed to treat all forms of the condition, using every non-surgical and surgical option available.

Michelle Welborn, M.D., pediatric orthopaedic surgeon at the Portland Shriners Hospital, is one of only 12 current surgeons across the country certified to perform this innovative surgical procedure. Anterior vertebral body tethering (VBT) is a promising alternative for certain patients with scoliosis who meet very specific criteria, are still growing, and for whom surgery is indicated. VBT is an alternative to spinal fusion  ..

“While VBT is not right for everyone, it is a great alternative to fusion particularly for those patients where preserving motion is critical, such as those patients with curves in their lower spine, athletes and dancers. Furthermore, recovery tends to be faster so patients can return to activities faster than they would following a fusion.” 

The FDA’s clearance is for The Tether™, which uses patented methods and techniques developed by medical staff of Shriners Hospitals for Children — Philadelphia, and performed at the Portland Shriners Hospital. It is the first commercially available product used specifically for VBT.

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.

Customized treatment

Whether a child has common idiopathic adolescent scoliosis or a highly complex spine deformity, they deserve an individualized treatment plan utilizing the most advanced and innovative techniques. The spine team at the Portland Shriners Hospital takes a fully integrated team approach to the treatment of pediatric spine conditions, with a focus on early detection and fusionless treatments for the growing spine, as well as offering minimally invasive and advanced surgical techniques for those children who do require spinal fusions.

Fast facts: Scoliosis

The key in all care and treatments of scoliosis is prevention; the earlier detection happens in children and adolescents, the better possible outcomes.

There are many types of scoliosis:

  • Neuromuscular scoliosis, related to underlying conditions affecting the nerves, including cerebral palsy and spina bifida
  • Scoliosis associated with a syndrome or other condition such as Marfan syndrome
  • Congenital scoliosis, associated with malformed vertebra (bones in the spine) and/or ribs
  • Idiopathic scoliosis, not related to another condition

About anterior vertebral body tethering

  • As with all medical care and procedures, results differ based on individual patients
  • Patients who opt for the tethering procedure can return to their routine activities, including sports, after about one month. In comparison, after a spinal fusion, it can take six months to a year to reach that point
  • Tethering may be an option for adolescent patients with scoliosis for whom wearing a brace is difficult for physical and/or psychosocial reasons