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.
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.
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.
presented.