The clinical study, which will recruit patients in the US, Canada and the UK, will assess whether the Braive growth modulation system is safe and effective in correcting the spine's curve in patients with juvenile or adolescent idiopathic scoliosis
Medical technology company Medtronic has commenced the paediatric clinical study of spinal tether for the treatment of scoliosis.
The company has recruited the first patient and completed the first surgical procedure in its BRAIVE IDE study to assess the safety and efficacy of the Braive growth modulation system to treat progressive adolescent idiopathic scoliosis (AIS).
The Braive device is part of Medtronic’s latest innovations in the pediatric spine category.
UK-based Newcastle Upon Tyne Hospitals NHS Foundation Trust has recruited the first patient in the clinical study.
According to the company, around 4% of children across the globe have scoliosis, which occurs when the vertebrae twist or rotate that may cause the spine to curve into a “C” or “S” shape rather than a straight line.
Using a braid secured to the spine with screws, the Braive growth modulation system helps in slowing growth on the curved side of the spine while enabling to continue the growth on the other side.
The clinical trial will assess whether the system is safe and effective in correcting the spine’s curve in patients with juvenile or adolescent idiopathic scoliosis.
Medtronic will recruit the patients in the prospective and multi-centre study in the US, Canada, and the UK.
Medtronic neuroscience portfolio’s cranial and spinal technologies business’ spine and biologics segment general manager and vice president Carlton Weatherby said: “Launching the BRAIVE IDE study is our latest step in bringing life-changing technologies to pediatric patients.
“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.”
The study evaluated 6,219 patients implanted with Micra VR TPS and 10,212 patients implanted with traditional TV-VVI pacemakers.