Globus Medical Announces FDA Approval for its Non-Fusion Scoliosis Correction System, the Latest Advancement for Young Patients with Idiopathic Scoliosis
15 Maggio 2023 - 10:30PM
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.
IndicationsThe 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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hereof.
Contact: Brian Kearns Senior Vice
President, Business Development and Investor Relations Phone:
(610)
930-1800 Email: investors@globusmedical.com www.globusmedical.com
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