Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis

Exclusion Criteria

• •A subject will be excluded from participating in this study for any of the following reasons:
• •Has undergone previous spinal fusion procedure(s) at the affected levels
• •Is pregnant or plans to become pregnant within the first 24-months of the study
• •Has a curve that requires instrumentation below L1
• •Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord)
• •Has any type of non-idiopathic scoliosis
• •Has a left-sided curve
• •Has an associated syndrome
• •Has a history of malignant hyperthermia
• •Has an active or significant risk of infection (immunocompromised)
• •Has inadequate tissue coverage over the operative site as per investigator's assessment
• •Has a suspected or documented allergy or intolerance to implant materials
• •Has a major psychiatric disorder / history of drug abuse that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation as per investigator's assessment (DSM-5 can be used as a reference)
• •Is a ward of the court/state
• •Has had prior ipsilateral or contralateral chest surgery
• •Has severe chronic lung disease (e.g., asthma, bronchiectasis)
• •Has poor bone quality, as determined by the investigator, that may limit anterior fixation
• •Is unwilling or unable to return for follow-up visits and/or follow intra-operative and/or postoperative instructions
• •Concurrent participation in another clinical study that may add additional safety risks and/or confound study results