Ongoing clinical trial
Treatment of early adolescent spinal deformity with the Scoli-Tether System
Although surgery is the only form of treatment that provides the lasting reduction of a deformed spine (idiopathic scoliosis), it does so at the expense of spinal motion. Also, fusion done early in the adolescent growth spurt may significantly limit growth. A new treatment that provides lasting control of the curve without these limitations would be a meaningful addition to the armamentarium of surgical treatments for AIS.
This research study involves the use of an investigational medical device, called MIScoli System (internal bracing). Spino modulation is developing and researching for the treatment of idiopathic scoliosis (scoliosis for which the cause is unknown), to reduce deformity and prevent its worsening in growing children/adolescents at high risk for curve progression while preserving motion.
The MIScoli System was honored to have been designated as a Breakthrough Device by the US Food & Drug Administration (FDA).