Developers: | Medtronic |
Branches: | Pharmaceuticals, medicine, healthcare |
2021: First patient using Braive
On September 22, 2021, Medtronic announced the enrollment of the first patient in a study of its Braive growth modulation system designed to treat scoliosis.
Medtronic completed the first surgical procedure as part of the Braive Research Device Exclusion (IDE) study, which evaluated the safety and effectiveness of a growth modulation system to treat advanced idiopathic [scoliosis' scoliosis]] in adolescents. The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust in the UK.
Braive uses a harness fixed to the spine with screws to slow growth on the curved side of the spine, while allowing continued growth on the other side. As part of the IDE study, the safety and efficacy of the system in correcting spinal curvature in patients with juvenile or adolescent idiopathic scoliosis in the US, Canada and the UK will be evaluated.
Launch of the Braive IDE study, this is our last step towards introducing technologies that change the lives of childhood patients. This gives us a unique opportunity to offer the most complete and integrated ecosystem of procedural solutions for pediatric surgeons, contributing to meaningful improvements in clinical outcomes for small patients, said Carlton Weatherby, Medtronic Vice President and CEO of Spine and Biologics in the Cranial and Spinal Technology Division. |
According to Medtronic, about 4% of children around the world suffer from scoliosis, which occurs when the vertebrae curve or rotate, which can lead to the spine curving in the form of a letter C or S, rather than a straight line. The Braive device is positioned as an innovative development of the company in the category of child spine, and the beginning of the study itself confirms the company's desire to constantly introduce innovations for patients of childhood.[1]