REFLECT™ is authorized by means of the FDA’s Humanitarian System Exemption pathway
AUDUBON, Pa., Could 15, 2023 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE: GMED), a number one musculoskeletal options firm, as we speak introduced the REFLECT™ Scoliosis Correction System has been granted approval from the US Food and Drug Administration, as the corporate’s first humanitarian machine. REFLECT™ is designed to right progressive scoliosis in younger sufferers whereas preserving movement, sustaining stability, and permitting for future modulated development.
In contrast to inflexible metallic rods for fusion, REFLECT™ makes use of a versatile, sturdy cord to harness the ability of innate affected person development for correction. The versatile cord is tensioned on the convex aspect to regulate the curve, whereas permitting development on the concave aspect. The implants could also be inserted utilizing a minimally invasive strategy by means of a number of small incisions between the ribs.
“Treating scoliosis within the rising spine presents challenges associated to lowered spinal mobility,” says Dr. Juan C. Rodriguez-Olaverri, board-certified orthopedic surgeon and Director of Pediatric Spinal Deformity Surgical procedure and Early Onset Scoliosis at NYU Langone. “REFLECT™ is an thrilling growth for curve correction that preserves freedom of movement in these younger sufferers, and employs their very own remaining development to assist restore the spinal curvature with out the necessity for fusion.”
Kelly Baker, Senior Vice President, Regulatory and Medical Affairs at Globus Medical, commented, “REFLECT™ has been obtainable internationally for a number of years, and Globus Medical may be very excited to make this method obtainable to sufferers in the USA. This progressive resolution highlights our dedication to addressing the medical wants of the rising spine and enhancing the standard of life in these kids. It’s the newest development in scoliosis remedy that gives a non-fusion possibility for sufferers and their mother and father, as they think about the very best remedy plan for his or her way of life and objectives.”
To be taught extra, go to GlobusMedical.com/merchandise/REFLECT.
The REFLECT™ Scoliosis Correction System is indicated for skeletally immature sufferers who require surgical remedy to acquire and preserve correction of progressive idiopathic scoliosis, who’ve a significant Cobb angle of 30 to 65 levels whose osseous construction is dimensionally ample to accommodate screw fixation, as decided by radiographic imaging. Sufferers ought to have failed bracing and/or are illiberal to brace put on.
About Globus Medical, Inc.
Globus Medical, Inc. is a number one musculoskeletal options firm based mostly in Audubon, PA. The corporate was based in 2003 by an skilled workforce of pros with a shared imaginative and prescient to create merchandise that allow surgeons to advertise therapeutic in sufferers with musculoskeletal problems. Further data might be accessed at http://www.globusmedical.com.
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