REFLECT system is indicated for skeletally immature young patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, while preserving motion, maintaining stability, and allowing for growth
FDA approves Globus’ REFLECT scoliosis correction system. (Credit: CDC on Unsplash)
US-based musculoskeletal solutions provider Globus Medical has received the US Food and Drug Administration (FDA) approval for its REFLECT Scoliosis Correction System.
REFLECT system is designed to correct progressive scoliosis in young patients while preserving motion, maintaining stability, and allowing for future modulated growth.
The US health agency approved REFLECT through its Humanitarian Device Exemption pathway.
The system is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 30º to 65º.
Also, for patients whose osseous structure is dimensionally suitable to accommodate screw fixation and/or with a failed bracing and/or who are intolerant to wearing braces.
Globus Medical regulatory and clinical affairs senior vice president Kelly Baker said: “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.”
Globus said that, unlike rigid metal rods for fusion, its REFLECT system leverages a flexible, durable cord to unlock the power of a patient’s innate growth for correction.
Treatment using the system involves implants that may be inserted using a minimally invasive approach through a few small incisions between the ribs.
The flexible cord is tensioned on the convex side to control the curve, and its concave side allows for tissue growth, said the medical device company.
NYU Langone paediatric spinal deformity surgery and early onset scoliosis director, and board-certified orthopaedic surgeon Juan C Rodriguez-Olaverri said: “Treating scoliosis in the growing spine presents challenges related to reduced spinal mobility.
“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.”
Earlier this year, Globus Medical and NuVasive signed an agreement to merge in an all-stock deal valued at $3.1bn to form a patient care-centric global musculoskeletal company.