Medtronic (NYSE:MDT) announced today that it enrolled the first patient in a study for its Braive growth modulation system.
Fridley, Minn.-based Medtronic also completed the first surgical procedure in the BRAIVE investigational device exemption (IDE) study evaluating the safety and effectiveness of the Braive growth modulation system for treating progressive adolescent idiopathic scoliosis.
The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom, according to a news release.
Braive 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 IDE study will evaluate the system’s safety and efficacy in correcting the spine curve in patients with juvenile or adolescent idiopathic scoliosis in the U.S., Canada and UK.
“Launching the BRAIVE IDE study is our latest step in bringing life-changing technologies to pediatric patients,” Medtronic VP & GM of spine & biologics within the cranial & spinal technologies business Carlton Weatherby said in the release. “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.”