The First of Its Kind
By Admin | September 05, 2019
Last month, the U.S. Food and Drug Administration approved the first spinal tether device designed to treat children and teenagers living with scoliosis.
The device, known as The Tether - Vertebral Body Tethering System, is intended to correct the most common form of scoliosis, called idiopathic scoliosis, in patients who have not responded to other conventional treatment options, including external bracing.
The device is intended to treat growing children and adolescents to target spinal curves that are nearing or have reached the degree at which surgical treatment is a viable option.
The Tether works by pulling the spine internally through a system of anchors and vertebral body screws and tension to pull the spine into the correct position as the patient grows.
Surgical treatment for scoliosis means spinal fusion surgery to help straighten and stabilize the back.
Idiopathic scoliosis is the sideways curvature of the spine. The cause of the condition is unknown, and it is the most common deformities in children. Most patients living with the disease are diagnosed between ages 10 and 18, while some may be diagnosed at an earlier age.
In most cases, treatment for the condition requires external bracing that helps to push the spine into correct curvature.
But, bracing does not always work. Nearly 7,000 patients in the U.S. develop progressive curvatures that do not respond to bracing each year.
These are the individuals for whom surgery is a solution.
But, some surgeries can result in unintended complications.
"We are here to reduce the risk of those complications," said Dr. Faisal R. Jahangiri of AXIS Neuromonitoring in Richardson, Texas.
AXIS does this by offering surgeons - and their patients - intraoperative neuromonitoring.
"We watch the patient's nerves and neural structures for changes that could result in serious lifelong consequences," said Jahangiri.
Lifelong consequences may include paralysis. This situation developed in the operating room where AXIS was monitoring a 19-year-old female having surgery to correct scoliosis.
Using Somatosensory Evoked Potentials (SSEP), Motor Evoked Potentials (TCeMEP), and Electromyography (EMG) to monitor the patient during pedicle screw placement, the attending AXIS technologist quickly noticed potentially devastating changes to the patient that caused the loss of motor-evoked responses in lower limbs.
The surgeon immediately removed the screws; the motor responses came back in the left leg and foot. However, the patient was unable to move her right leg and foot upon awakening.
The surgeon moved to cancel the surgery and sent the patient for an MRI to get a bigger picture of what was happening. Results of the MRI showed ischemic changes in the spinal cord at the thoracic vertebrae at the T11/T12 level due to medical breach of the pedicle wall.
Due to the damage, the patient was unable to move her right leg and also experienced severe burning in her left lower extremity.
"Although the patient went on to recover full motor function after rehabilitation, without neuromonitoring services during her surgery, she could have been left with permanent damage to the spinal cord," Jahangiri said.
Source: U.S. Food & Drug Administration. FDA approves first of its kind device to treat pediatric patients with progressive idiopathic scoliosis. 16 August 2019.
