New treatment for early onset scoliosis designated FDA breakthrough device
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A potential new treatment for early onset scoliosis, the Spring Distraction System by Cresco Spine, has received a breakthrough device designation from the FDA, according to a company press release.
The device allows for 3D-guided spinal growth even in extreme deformations and minimizes the number of operations needed to treat scoliosis in young patients, according to the release.
Described as a proprietary spring-based dynamic distraction system, the device works with posterior pedicle screw fixation, according to the release. Chief medical officer of Cresco Spine and orthopedic surgeon René Castelein, MD, PhD, said “a significant number of patients” are having success with the Spring Distraction System (SDS) in clinical exemption trials.
Calling the breakthrough device designation for the SDS a “significant milestone,” Cresco Spine CEO Dennis Magermans, PhD, said it “underscores the potential of our innovative spinal implant system to make a real difference in the lives of patients suffering from this debilitating spinal condition.”
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