FDA approves scoliosis correction system for pediatric idiopathic scoliosis
The REFLECT Scoliosis Correction System from Globus Medical is intended to correct progressive scoliosis in pediatric patients while simultaneously maintaining stability and motion as well as allowing for future modulated growth.
FDA approves scoliosis correction system for pediatric idiopathic scoliosis: © Grandbrothers - stock.adobe.com
Globus Medical has announced the FDA approval of its REFLECT Scoliosis Correction System for the treatment of pediatric patients with idiopathic scoliosis.
Specifically, the FDA has indicated the approval for skeletally immature patients who necessitate surgical treatment to correct and maintain correction of progressive idiopathic scoliosis. Patients are required to have a major Cobb angle of 30 to 65 degrees and an osseous structure dimensionally adequate for screw fixation, which will be determined by radiographic imaging. Additionally, the FDA says patients should have failed bracing and/or be able to tolerate brace wear.
According to the FDA, idiopathic scoliosis is the most common spinal deformity in pediatric patients 10 to 18 years and is characterized by a sideways curvature of the spine; the cause is unknown.
The REFLECT Scoliosis Correction System is intended to correct progressive scoliosis in pediatric patients while simultaneously maintaining stability and motion as well as allowing for future modulated growth.
REFLECT is designed to use a flexible, durable cord to use the power of natural patient growth for correction. According to Globus, the system may be inserted through small incisions between the ribs.
“Treating scoliosis in the growing spine presents challenges related to reduced spinal mobility,” said Juan C. Rodriguez-Olaverri, MD, PhD, orthopedic surgeon and director of Pediatric Spinal Deformity Surgery and Early Onset Scoliosis at NYU Langone. “REFLECT is an exciting development for curve correction that preserves freedom of motion in these young patients and employs their own remaining growth to help repair the spinal curvature without the need for fusion."
Reference:
Globus medical announces FDA approval for its non-fusion scoliosis correction system, the latest advancement for young patients with idiopathic scoliosis. GlobeNewswire News Room. May 15, 2023. Accessed May 16, 2023. https://www.globenewswire.com/news-release/2023/05/15/2669363/0/en/Globus-Medical-Announces-FDA-Approval-for-its-Non-Fusion-Scoliosis-Correction-System-the-Latest-Advancement-for-Young-Patients-with-Idiopathic-Scoliosis.html
