Zimmer Biomet's Tether Vertebral Body Tethering System Receives First-Ever FDA Approval for Pediatric and Adolescent Idiopathic Scoliosis

On August 19, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Zimmer Biomet Holdings (Zimmer) announced that its medical device, the Tether™ Vertebral Body Tethering System, had received FDA approval for the treatment of adolescent idiopathic scoliosis.

Idiopathic scoliosis is a common spinal deformity in children, characterized primarily by uneven shoulder height, asymmetric scapular positioning, and deviation of the spine from the midline. The pathogenesis of this condition remains unclear, and the current standard of care is conservative, non-surgical management, such as the use of external bracing to correct spinal curvature.

Approximately 6,800 patients in the United States experience progression of idiopathic scoliosis annually, for whom conventional conservative treatments prove ineffective. These patients require spinal fusion surgery to permanently correct and stabilize the spinal curvature. However, this procedure carries high risks, is associated with numerous postoperative complications, and entails a significant probability of requiring revision surgery.

Tether™ Vertebral Body Tethering System provides a highly effective alternative for patients with idiopathic scoliosis, being the first FDA-approved medical device for the treatment of pediatric and adolescent idiopathic scoliosis.

Zimmer, founded in 1927 and headquartered in Indiana, USA, is a leading medical device company. The company is dedicated to the design, development, manufacturing, and marketing of spinal implants, artificial joints, dental implants, and other orthopedic products, primarily for applications in sports medicine, joint reconstruction, dental restoration, spine care, and bone repair. Zimmer’s mission is to improve patient outcomes and meet their healthcare needs through advanced technologies. The company was listed on the New York Stock Exchange in August 2001 under the ticker symbol ZBH.

Zimmer also boasts a specialized dental care division, Zimmer Biomet Dental, which primarily develops dental implants and implant technologies to provide patients with high-quality oral care services. The division is supported by a team of experienced engineers, scientists, and clinicians, and currently holds 319 patents, with an additional 161 patents pending.

Zimmer aims to provide patients with comprehensive diagnosis, treatment, and rehabilitation solutions, boasting outstanding achievements in dental implants and spinal correction. The company’s researchers have published more than 650 medical-related articles and have received numerous honors, including the Medical Design Excellence Awards (MDEA).

Dr. Raquel Peat, Director of the Office of Orthopedic Devices at the FDA, stated, “For pediatric and adolescent patients with idiopathic scoliosis, spinal fusion surgery is the only option when external bracing proves ineffective. However, the novel device we have approved today offers a new treatment alternative, enabling these patients to achieve improved outcomes without undergoing surgery.”

Dr. Amy Abernethy, Principal Deputy Commissioner of the FDA, stated, “Following the market launch of Zimmer’s innovative medical device, we will continue to monitor its therapeutic efficacy and patient feedback. Ensuring patient health and safety remains the top priority in medical device development, while real-world medical data also drives innovation in the field.”

(Compiled by Xu Xiaoxue)