Spinologics’s Spino Modulation today announced that it received FDA breakthrough device designation for its MIScoli vertebral body tethering device.
Spino Modulation designed the system to treat scoliosis in young adolescents.
Vertebral body tethering (VBT) is a less invasive alternative to spine fusion, which is the standard of care for adolescents who need surgery to correct a curvature of the spine. According to the company, MIScoli is one of a few VBT devices under investigation or limited market release in many countries.
Spinologics is performing an ongoing clinical trial to research the MIScoli system as a treatment option for idiopathic scoliosis to reduce deformity and prevent its worsening in growing children who are at high risk for curve progression while also preserving motion.
