As First Patient Is Enrolled in the Clinical Trial of Braive™
Growth Modulation System, Study Reaffirms Medtronic's Commitment to
Pediatric Spine Innovation
DUBLIN, Sept. 22, 2021 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), the global leader in medical technology, today
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 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.
"There continues to be an unmet need for medical devices
specifically tailored to pediatric patients," said Andrew Bowey, consultant orthopedic surgeon,
Newcastle Hospitals, and BRAIVE IDE study principal
investigator. "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."
"Launching the BRAIVE IDE study is our latest step in bringing
life-changing technologies to pediatric patients," said
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. "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."
To learn more about Medtronic Spine & Biologics, visit
Medtronic.com/SpineSurgery.
About Medtronic
Medtronic plc (www.medtronic.com),
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.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
References
- Julien C, Gorman KF, et al. "Towards a comprehensive diagnostic
assay for scoliosis." Per Med. 2013 Jan;10(1):97-103. doi:
10.2217/pme.12.117.
- "Scoliosis." American Association of Neurological Surgeons.
https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Scoliosis.
Accessed Aug. 30, 2021.
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SOURCE Medtronic plc