Globus Medical Announces FDA Approval for its Non-Fusion Scoliosis Correction System, the Latest Advancement for Young Patients with Idiopathic Scoliosis
Tuesday, May 16, 2023
Globus Medical, Inc., a renowned company specializing in musculoskeletal solutions, has announced that its REFLECT™ Scoliosis Correction System has received approval from the US Food and Drug Administration (FDA) as the company's first humanitarian device. The REFLECT™ system is specifically designed to address progressive scoliosis in young patients while preserving their mobility, stability, and potential for future growth.
In contrast to rigid metal rods used in fusion procedures, REFLECT™ employs a flexible and durable cord that harnesses the natural growth of the patient for correction. By applying tension on the convex side of the curvature, the flexible cord effectively controls the scoliotic curve while allowing growth on the concave side. The implants can be inserted using a minimally invasive approach, requiring only a few small incisions between the ribs.
Dr. Juan C. Rodriguez-Olaverri, a board-certified orthopedic surgeon and Director of Pediatric Spinal Deformity Surgery and Early Onset Scoliosis at NYU Langone, highlights the challenges faced when treating scoliosis in growing spines, particularly the limitations on spinal mobility. He expresses enthusiasm for REFLECT™ as an exciting development in curve correction, as it not only preserves freedom of motion in young patients but also utilizes their natural growth to repair spinal curvature without the need for fusion.
Kelly Baker, Senior Vice President of Regulatory and Clinical Affairs at Globus Medical, expresses the company's excitement in making the REFLECT™ system available to patients in the United States after its successful international use over the past few years. The system represents an innovative solution that demonstrates Globus Medical's commitment to addressing the clinical needs of growing spines and improving the quality of life for children affected by scoliosis. By providing a non-fusion option, REFLECT™ offers patients and their parents an alternative treatment approach that aligns with their lifestyle and goals, marking a significant advancement in scoliosis treatment.