Globus Gains FDA Approval of REFLECT Scoliosis Correction System

Globus Medical has been granted U.S. Food and Drug Administration (FDA) approval for its REFLECT scoliosis correction system. REFLECT is the company’s first humanitarian device.
 
REFLECT was engineered to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth. It uses a flexible, durable cord—unlike rigid metal fusion rods—to harness innate patient growth for correction.
 
The flexible cord is tensioned on the convex side to control the curve and allows growth on the concave side. The implants can be inserted via a minimally invasive approach through a few small incisions between the ribs, according to Globus.
 
“Treating scoliosis in the growing spine presents challenges related to reduced spinal mobility,” Dr. Juan C. Rodriguez-Olaverri, board-certified orthopedic surgeon and Director of Pediatric Spinal Deformity Surgery and Early Onset Scoliosis at NYU Langone, told the press. “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.”
 
Kelly Baker, senior VP, regulatory and clinical affairs at Globus, added, “REFLECT has been available internationally for several years, and Globus Medical is very excited to make this system available to patients in the United States. This innovative solution highlights our commitment to addressing the clinical needs of the growing spine and improving the quality of life in these children. It is the latest advancement in scoliosis treatment that provides a non-fusion option for patients and their parents, as they consider the best treatment plan for their lifestyle and goals.”
 
Earlier this year, Globus entered into a well-publicized, $3.1 billion merger deal with spine surgery tech maker NuVasive. The transaction is expected to close in mid-2023.