The ZimVie Tether helps kids with scoliosis — if they can get it in time
The ZimVie Tether system is FDA approved for adolescent idiopathic scoliosis under a humanitarian device exemption. [Image courtesy of ZimVie]
But for every patient the clock is ticking, as children are only eligible if they have enough growth ahead of them for the technology to make a difference. And all too often, insurance companies can delay the treatment so long that patients are no longer eligible if and when insurers approve the procedure.
ZimVie SVP and Global Spine President Rebecca Whitney spoke about the systems development and commercialization with ZimVie Spine Global R&D Director Ryan Watson today at DeviceTalks Boston.
“We’ve worked for years to make sure that we have the right options available for these kids because it is a special patient population,” Whitney said. “… When you talk about kids who are typically aged 10 to 15, we are hopefully improving their lives for years and years to come. We take it very seriously and it is something that all of us are very passionate about.”
What is adolescent idiopathic scoliosis?
Rebecca Whitney is ZimVie’s global spine president. [Photo courtesy of ZimVie]
“Idiopathic is basically code for ‘we don’t know.’ It’s not really clear as to why this happens, what creates the phenomenon,” Whitney said.
The condition can be lived with but causes issues as it progresses, including aesthetic issues and potentially life-threatening heart and lung compression. Traditional standards of care have had varying degrees of effectiveness.
“The first line of defense is a wait-and-see approach because a lot of times these curves don’t progress to the point where they do need intervention,” Whitney said. “If they do, bracing is usually the first order of treatment. Bracing can be effective, but the challenge with bracing is these kids are required to wear a brace from 12 to 20 hours a day.”
Bracing can range from uncomfortable to painful, and the biggest reason why it fails is because patients don’t want to wear them. If bracing doesn’t work, the historical standard of care is fusion.
“Posterior spinal fusion is very effective at straightening out the spine,” Whitney said. “It does that part very well, but it’s also very invasive. … You’ve got screws and rods placed all up and down the spine, and then you’re fusing that spine in place. It fixes the curvature of the spine, but it comes with long-term, potential limitations as the patient goes on to grow and continue with their active lifestyle.”
Vertebral body tethering for adolescent idiopathic scoliosis
A less-invasive alternative to fusing for adolescent idiopathic scoliosis is motion-preserving vertebral body tethering.
“Instead of fusing the back all up and down, you have these anchor points and you’re able to use basically a shoestring of sorts. And as the patient grows, that spine is able to straighten out without having to fuse the spine in place,” Whitney said. “We believe that for patients who are indicated, this is a really great solution and it offers the benefits of fusion while also preserving lifestyle. And for the most part, these kids are very active and looking to get back to a very healthy level of a lifestyle.”
