The US Food and Drug Administration (FDA) has granted approval for Globus Medical’s REFLECT Scoliosis Correction System.
Claimed to be the company’s first humanitarian device, REFLECT is intended for the correction of progressive scoliosis in young patients and preserve motion, while maintaining stability and enabling future modulated growth.
This system is designed for skeletally immature patients with progressive idiopathic scoliosis who need surgery to achieve and maintain correction of the spine.
It is suitable for those with a Cobb angle ranging from 30 to 65 degrees, whose osseous structure is dimensionally sufficient for accommodating screw fixation, as confirmed by radiographic imaging.
REFLECT harnesses the innate growth of patients for correction by utilising a flexible and durable cord, in contrast to the inflexible metal rods used in fusion.
To control the curve, the flexible cord is tensioned on the convex side, while accommodating growth on the concave side.
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The implants can be placed with a minimally invasive technique by making a few small incisions between the ribs.
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 US.
“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.”