REFLECT™ is approved through the FDA’s Humanitarian Device Exemption pathway
AUDUBON, Pa., May 15, 2023 (GLOBE NEWSWIRE) -- Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced the REFLECT™ Scoliosis Correction System has been granted approval from the US 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, commented, “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.”
To learn more, visit GlobusMedical.com/products/REFLECT.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature patients who require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, who have a major Cobb angle of 30 to 65 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging. Patients should have failed bracing and/or are intolerant to brace wear.
About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.
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Source: Globus Medical