The Tether

Zimmer Biomet has announced FDA approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. A press release reports that The Tether uses a strong, flexible cord, rather than 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. This growth modulation approach now offers select, well-indicated patients an option to achieve a straighter spine, without the limitations of spinal fusion. Additionally, unlike fusion metallic rods, The Tether is positioned using an endoscopic minimally invasive approach through a few small openings between the ribs.

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 to bring innovative paediatric solutions to market and represents the first approval order for a humanitarian use device in spinal paediatrics within the last 15 years. Considering the recent removal (per FDA final rule) of many semi-rigid stabilisation systems that were historically used for anterior vertebral body tethering (AVBT), according to the press release, this solution arrives at a critical time for continuation of care.

Amer Samdani (Shriners Hospitals for Chilren, Philadelphia, USA) says: “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. The Tether provides clinicians who take care of children with spinal curves another option for treatment. When use in the appropriately selected patient, the results are dramatic with respect to curve control and maintenance of a mobile spine.”

Jim Cloar, president of Zimmer Biomet Spine, says: “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. Working together, clinicians, the FDA and Zimmer Biomet have given surgeons an important fusion-less scoliosis treatment option for their paediatric 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 finalise 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, multicentre, prospective research studies focused on paediatric spinal deformity.