Zimmer Biomet Holdings Inc. said the U.S. Food and Drug Administration approved its product — the Tether — to treat scoliosis, a type of spine deformity, in children.
Current treatment for scoliosis involves an invasive operation to attach metal rods, hooks, wires or screws on the spine to align the vertebrae. Tether is an anterior vertebral body tethering solution that uses a flexible cord instead of metal rods and is positioned using a minimally invasive procedure that requires few small openings between the ribs.
The treatment got clearance under the FDA's humanitarian device exemption pathway, which provides approval for products without requiring evidence of effectiveness.
Warsaw, Ind.-based healthcare equipment company Zimmer Biomet and the U.S. regulator will finalize a new clinical study to monitor the outcomes in patients treated with the Tether.