(RxWiki News) A first-of-its-kind device to treat the most common form of scoliosis has gotten the green light from the US Food and Drug Administration (FDA).
The FDA recently approved this device, called The Tether – Vertebral Body Tethering System, for children and adolescents. This device is intended to treat idiopathic scoliosis that has not responded to external bracing.
The FDA noted that this new device is an option for children whose spines have reached the range in which surgical treatment is an option.
Idiopathic scoliosis, the most common form of scoliosis, is a condition with an unknown cause. It is marked by a sideways curvature of the spine. This type of scoliosis is typically diagnosed between 10 and 18 years old.
Currently available treatment for this condition includes bracing. For the 6,800 children who do not respond to bracing each year, spinal fusion surgery is the next option. Although this type of surgery is helpful, it restricts the motion of the spine and, as a result, may lead to long-term complications like pain.
With that said, this recently approved tethering device offers a new option for children whose options have been limited.
The Tether – Vertebral Body Tethering System is different from other treatment options because it is specifically designed to continually correct the spine curvature but maintains a fuller range of motion. This differs from the restrictions seen with spinal fusion surgeries.
The device consists of the following:
- Vertebral body screws
- A flexible cord called a tether
The tether, connected to the screws, is adjusted to a certain position to partially correct the curve. Over time, the tether promotes growth on the opposite side of the spine while slowing growth on the curved side of the spine. This process enables additional correction of the spine curvature as the patient grows.
After the device has been set, a health care professional will monitor progress. This monitoring will track the spinal curvature and identify potential problems.
The FDA reviewed data from 57 patients who were treated with this device. After two years, 43 patients experienced sufficient improvement in their spine curvature and did not need spinal fusion.
The most common adverse events included overcorrection of the curvature, tether breakage and a collapsed lung.
This device's approval was granted to Zimmer Biomet Spine.
Ask your health care professional any questions you have about scoliosis and the approved treatments.
Written by Anyssa Garza, PharmD, BCMAS