August 16, 2019
2 min read
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Zimmer Biomet receives FDA approval for spinal tether device for idiopathic scoliosis
Zimmer Biomet Holdings Inc. announced it has received FDA approval for The Tether, the first spinal tether device intended for use in children and adolescents to correct idiopathic scoliosis that has not responded to conservative treatment.
“For children and adolescent patients with idiopathic scoliosis that does not respond favorably to bracing, treatment options have been limited to fusion surgeries,” Capt. Raquel Peat, PhD, director of the Office of Orthopedic Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “Today’s approval provides access to a new treatment option that could improve quality of life for patients with idiopathic scoliosis.”
Available through the FDA’s humanitarian device exemption pathway, The Tether is an anterior vertebral body tethering solution that uses a strong, flexible cord instead of metal rods to pull on the outside of a scoliosis curve to initially straighten the spine while the inside of the curve is left free to grow, according to a company press release.
Clinical data presented to the FDA from 57 patients who received The Tether showed sufficient improvement of the curvature of the spine in 43 patients at 2 years. Overcorrection of the curvature, tether breakage and pneumothorax were reported as the most common serious adverse events, according to results, while pain, respiratory problems, nerve injuries and bleeding were reported as general complications consistent with any spinal surgical procedure.
“The Tether embodies Zimmer Biomet’s mission to improve the quality of life for people around the world. This collaboration demonstrates how a focused, shared purpose can fundamentally change the way we approach treatment of diseases like scoliosis,” Jim Cloar, president of Zimmer Biomet Spine, said in the release. “Working together, clinicians, the FDA and Zimmer Biomet have given surgeons an important fusion-less scoliosis treatment option for their pediatric patients. This procedure gives kids the best option for maintaining spine mobility and reaching their full potential.”
References:
https://investor.zimmerbiomet.com/news-and-events/news/2019/08-16-2019-160833526
www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pediatric-patients-progressive-idiopathic-scoliosis
Perspective
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Baron Lonner, MD
The FDA’s recent approval of The Tether Vertebral Body Tethering System will create new opportunities for patients and surgeons alike, allowing surgeons to provide a non-fusion scoliosis correction option to their patients and giving patients the ability to opt for the minimally invasive procedure that many have been requesting for some time. While the approval of this device under the humanitarian device exemption (HDE) regulatory pathway requires institutional review board approval for each institution in which the procedure is to be performed, this critical step of approval will give surgeons the opportunity to study outcomes among a larger cohort of patients than the single center data submitted for the regulatory approval.
My team and I have extensive experience in performing vertebral body tethering (VBT) at our center. Patients (families) seeking out this procedure are attracted to the non-fusion aspect of the operation with at least partial preservation of motion in the operated segments. Unlike spinal fusion, VBT is a reversible procedure, and there is potential for less adjacent segment disc degeneration compared to spinal fusion, which will be determined only with long-term follow-up.
The drawbacks include the potential for overcorrection of the primary curvature during growth, tether cord breakage and a lack of long-term follow-up beyond 5 years. There is also a learning curve for this as for all innovative procedures, and hands-on training courses and mentorship from more experienced surgeons is required in order to maintain the highest level of safety.
The device is currently only indicated for still-growing individuals, although future alternatives may permit fusion-less scoliosis correction in skeletally mature patients. Applications of the technique may expand as data and experience are collected, and I have no doubt that the FDA approval will lead to a better understanding of the role of this procedure in the treatment of the scoliosis patient and potentially improved outcomes.
Baron Lonner, MD
Chief of minimally invasive scoliosis surgery
Mount Sinai Hospital
Professor of orthopedic surgery
Icahn School of Medicine
New York
Disclosures: Lonner reports he is a paid consultant of Zimmer Biomet Spine and is a developer of The Tether (Zimmer Biomet Spine) for which he will receive royalties.
