The U.S. Food and Drug Administration has just approved a new tool that may help select young people suffering from scoliosis, a sideways curvature of the spine.
Warsaw-based Zimmer Biomet Holdings Inc. (NYSE: ZBH) announced FDA approval for The Tether, a flexible device that is a fusion-less alternative for patients requiring surgery.
The company says the current surgical treatment for scoliosis is an invasive operation involving large incisions and the insertion of metal rods along both sides of the spine.
Zimmer Biomet’s anterior vertebral body tethering (AVBT) uses a strong, flexible cord to pull on the outside of a scoliosis curve to initially straighten the spine. Instead of large incisions, the company says physicians can use a less-invasive endoscope to insert the device through small openings between the ribs.
"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," said Dr. Amer Samdani, chief of surgery for Shriners Hospitals for Children in Philadelphia.
Zimmer Biomet says its Tether, similar to a strong tension band, will not work for all scoliosis patients, but it is an option for certain pediatric patients.
“When utilized in the appropriately selected patient, the results are dramatic with respect to curve control and maintenance of a mobile spine" said Samdani.
Zimmer Biomet says the approval marks the culmination of more than 5 years of cooperation between the company and the FDA. Further clinical studies will be conducted to monitor patient outcomes, according to the company.