Medtronic plc Begins Pediatric Clinical Trial of Spinal Tether for Treatment of Scoliosis
September 22, 2021 at 10:00 am EDT
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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. 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. 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.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).
MEDTRONIC PLC 
