Current regulatory news

FDA approval for non-fusion scoliosis correction system

Globus Medical Inc.’s REFLECT scoliosis correction system has been granted approval from the U.S. Food and Drug Administration as the company’s first humanitarian device. REFLECT is designed to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth.

Unlike rigid metal rods for fusion, REFLECT uses a flexible, durable cord to harness the power of innate patient growth for correction. The flexible cord is tensioned on the convex side to control the curve, while allowing growth on the concave side. The implants may be inserted using a minimally invasive approach through a few small incisions between the ribs.

“Treating scoliosis in the growing spine presents challenges related to reduced spinal mobility,” says Dr. Juan C. Rodriguez-Olaverri, board-certified 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.”

Kelly Baker, senior vice president, regulatory and clinical affairs at Globus Medical, comments, “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.”

GLOBUS MEDICAL