In September, 2021 Medtronic announced that it 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 juvenile (JIS) or adolescent (AIS) idiopathic scoliosis. The first patient was recruited by The Newcastle Upon Tyne Hospitals NHS Foundation Trust, United Kingdom.
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.
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.
About 4% of children globally have scoliosis, making it one of the most common pediatric orthopedic deformities.1 It occurs when the vertebrae twist or rotate, causing the spine to curve into a “C” or “S” shape, rather than a straight line. It typically occurs in children and impacts girls more often than boys. Standard treatment options may include braces or spinal fusion surgery. According to the National Scoliosis Foundation, an estimated 30,000 children a year receive a brace to treat their condition, while 38,000 patients are treated with spinal fusion.2 While successful in correcting the spine’s curve, spinal fusion causes vertebrae to fuse together into a single bone, which stops growth in that area of the spine.
About Medtronic
Medtronic plc , headquartered in Dublin, Ireland, is among the world’s largest medical technology, services, and solutions companies – alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals, and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.www.medtronic.com