Tether, approved as a humanitarian device by the FDA in 2019, treats skeletally immature patients. These patients require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. They present a major Cobb angle of 30 to 65 degrees with an osseous structure dimensionally adequate to accommodate screw fixation. Patients should have failed bracing and/or be intolerant to brace wear.
ZimVie Global Spine President Rebecca Whitney spoke about the system’s development and commercialization last year at DeviceTalks Boston.
More than 50 surgeons have performed VBT using the Tether system to treat adolescent idiopathic scoliosis patients. Dr. Baron Lonner, who has treated scoliosis for 28 years, called the Tether “an amazing advance.” Lonner said it enables the correction of scoliosis while avoiding fusion, according to a news release. It also brings a faster return to sports and other activities. The chief of minimally invasive scoliosis surgery and pediatric spine at Mount Sinai Hospital called it “a game-changer.”
“Having brought this technology to over 2,000 children is a milestone that serves as a reminder of our commitment to put patients first, especially those for whom our products can have such profound and prolonged impact,” said Whitney. “The Tether is an important and inspirational part of our motion preservation portfolio. We remain dedicated to developing the market for vertebral body tethering and restoring daily life for this special group of patients.”
