WARSAW, Ind.—Zimmer Biomet, Inc., a global leader in musculoskeletal healthcare, announced today that the U.S. Food and Drug Administration has approved their system The Tether for treatment of scoliosis, providing a fusionless alternative for young patients who require surgery.
The current surgical treatment for scoliosis is an invasive operation involving large incisions, extensive soft tissue disruption and restriction of spinal motion, with metal rods inserted along both sides of the spine to secure and align the vertebrae. Surgeons have tirelessly searched for alternative non-fusion surgical approaches to address scoliosis without limiting the skeletal development of these patients who are active and still growing.
Zimmer Biomet's anterior vertebral body tethering (AVBT) solution, The Tether, uses a strong and flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten the spine. The inside of the curve is left free to grow. This growth modulation approach now offers select, well-indicated patients an option to achieve a straighter spine, without the limitations of spinal fusion. And unlike fusion metallic rods, The Tether is positioned utilizing an endoscopic minimally invasive approach through a few small openings between the ribs.
The Tether is designed to treat skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. To be selected for this treatment, patients should have failed bracing and/or be intolerant to brace wear.
“Often growth in children with scoliosis results in curve progression. With AVBT, that growth can be harnessed to gradually further correct the tethered portion of the spine," noted Dr. Amer Samdani, board-certified neurosurgeon and chief of Surgery for Shriners Hospitals for Children in Philadelphia. “The Tether provides clinicians who take care of children with spinal curves another option for treatment. When utilized in the appropriately selected patient, the results are dramatic with respect to curve control and maintenance of a mobile spine.”
As an emerging treatment for a select patient population, The Tether is available through the FDA’s humanitarian device exemption (HDE) pathway. This approval marks the culmination of more than five years of cooperation between the FDA and Zimmer Biomet, and represents the first approval order for a humanitarian use device in spinal pediatrics within the last 15 years. Considering the recent removal (per FDA final rule) of many semi-rigid stabilization systems that were historically used for AVBT, this solution arrives at a critical time for continuation of care.
“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,” said Jim Cloar, president of Zimmer Biomet Spine. “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.”
Collaboration will continue as Zimmer Biomet and the FDA finalize a new clinical study for The Tether to optimally monitor patient outcomes. For the new study, Zimmer Biomet is excited to partner with the Harms Study Group, a worldwide cohort of surgeons with over 20 years of productivity who perform comprehensive, multi-center, prospective research studies focused on pediatric spinal deformity.