Medtronic has enrolled the first subject and completed the first surgical procedure in its paediatric clinical trial of the Braive growth modulation system to treat progressive adolescent idiopathic scoliosis (AIS).
The BRAIVE IDE trial enrolled the first participant at The Newcastle Upon Tyne Hospitals NHS Foundation Trust in the UK.
Scoliosis is considered one of the most common paediatric orthopaedic deformities and develops due to twisting or rotating of the vertebrae, which causes the spine to curve into a ‘C’ or ‘S’ shape instead of growing in a straight line.
The condition usually develops in children and current standard treatment options are braces or spinal fusion surgery.
As part of Medtronic’s paediatric spine portfolio, Braive uses a braid held to the spine with screws to slow growth on the spine’s curved side while allowing the continuation of growth on the other side.
The prospective, multi-centre BRAIVE IDE trial will assess the safety and effectiveness of the growth modulation system in correcting the curve of the spine in juvenile or AIS patients.
In addition to the UK, participants for the trial will be recruited across the US and Canada.
Medtronic spine and biologics vice-president and general manager Carlton Weatherby said: “As image guidance and navigation compatibilities extend further into additional spinal implant systems indicated for paediatric populations, they are coupled with a rapid cadence of transformative implant innovation.
“This uniquely positions us to offer the most comprehensive and integrated ecosystem of procedural solutions to paediatric spine surgeons driving meaningful improvements in clinical outcomes for young patients.”
BRAIVE IDE is designed to enrol 25 subjects, with a change in pre-operative Cobb angle versus the Cobb angle at 24 months after surgery being the primary outcome.
Another primary outcome measure in the trial is the number of secondary spinal surgeries determined as treatment failure up to 24 months after the Braive surgery.
Last month, Medtronic signed a definitive agreement to acquire ear, nose and throat medical technology company Intersect ENT.