Medtronic plc has enrolled its first patient and completed the first surgical procedure in its BRAIVE IDE study, which will evaluate the safety and effectiveness of the Braive growth modulation system for treatment of progressive Adolescent Idiopathic Scoliosis (AIS).
The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom. The device is Medtronic’s latest innovation in the pediatric spine category, and the study’s initiation reaffirms the company’s commitment to continued innovation for pediatric patients, the company notes in a media release.
Braive Growth Modulation System
The Braive growth modulation system uses a braid secured to the spine with screws to slow growth on the curved side of the spine, while allowing growth to continue on the other side. The BRAIVE IDE study will evaluate whether the system is safe and effective in correcting the spine’s curve in patients with juvenile or adolescent idiopathic scoliosis. The prospective, multi-center study will enroll patients in the United States, Canada, and the United Kingdom, per the release.
“There continues to be an unmet need for medical devices specifically tailored to pediatric patients. The Braive system is designed to correct scoliosis while allowing the spine to continue to grow, which is important for adolescents who are experiencing their most significant period of growth. I’m excited about its potential and the ability to bring this study to my patients who may benefit.”
— Andrew Bowey, consultant orthopedic surgeon, Newcastle Hospitals, and BRAIVE IDE study principal investigator
“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 pediatric 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 pediatric spine surgeons driving meaningful improvements in clinical outcomes for young patients.”
— Carlton Weatherby, vice president and general manager of Spine & Biologics within the Cranial & Spinal Technologies business, which is part of the Neuroscience Portfolio at Medtronic
[Source(s): Medtronic plc, PR Newswire]