Tuesday, January 16, 2018
Vertebral Body Tethering for Scoliosis (Part 3)
In Medicine, and in particular the area of spine deformity, the development of new treatments and technologies which can demonstrate improved outcomes, lower frequencies of complications, and/or faster recovery can create a “buzz” and enthusiasm depending on its potential of improvement. Physicians typically see these innovations earlier than the general public at medical meetings and read about them in peer-reviewed medical journals. Slightly later the medical media, followed by mainstream media, begin to report on the new medical technologies, especially if these treatments have developed some traction amongst physicians. One such technology is Vertebral Body Tethering (VBT) for scoliosis in the growing spine.
As detailed in previous postings on this blog there is significant potential for this technology, but little scientific evidence of its efficacy in humans. At present there are no approved implant systems in the U.S. which are FDA-approved for scoliosis. Spine implants used for VBT are being used in an off-label or unlabeled manner in the U.S. It is important to understand that innovations, especially in area of surgical spine deformity treatment, advances typically occur faster than does FDA approval. So innovations without FDA approval does not categorically mean they are unsafe or do not work, rather there is an absence of sufficient high-level of medical evidence to prove these devices are safe and efficacious to the FDA, who demands very high level of scientific proof. Prior to FDA approval implant systems, such as VBT, exist in a “grey” area. This can be frustrating to patients and caregivers who are anxious for advances in medicine, yet there is scant medical literature to help them navigate treatment options.
In the next blog post the complications of VBT will be presented.