NuVasive’s MRI has received FDA clearance under certain conditions on patients treated with its Magec system; this is the only noninvasive technology for growth modulation in pediatric spinal deformities that has received such clearance from the FDA.
Patients with early-onset scoliosis typically suffer from comorbidities that make treatment complex and often require them to undergo many MRI scans. Often, the lack of guidance on MR conditions has proven to be a hurdle for some surgeons in widely embracing Magec as a treatment option for such patients.
The FDA clearance includes MR conditions that use a 1.5 Tesla (T) static magnetic field MRI machine at a maximum spatial field gradient of 3000 gauss/cm (30 T/m) with a maximum MR system reported, whole-body averaged absorption rate of 0.5 W/kg at 1.5T. The Magec system is expected to produce a maximum temperature rise of no more than 3.7° Celsius after 15 minutes of continuous scanning, under the scan conditions defined.
“Having clear, defined guidance for conditional MRI compatibility with Magec helps alleviate uncertainty that may have limited surgeons from using the Magec system,” says Suken A. Shah, MD, division chief of the spine and scoliosis center and clinical fellowship director at the Nemours/Alfred I. duPont Hospital for Children in Wilmington, Del. “This clearance opens up the door for more patients and their families to benefit from this life-changing technology.”
Adding, Jason Hannon, president and COO at NuVasive, says, “As the only noninvasive growth modulation system on the market, this clearance is a key milestone in overcoming a known barrier in the treatment of children with [early onset scoliosis]. “NuVasive is consistently on the cutting-edge of the latest treatment options and we work diligently to bring that innovation to as many patients as possible around the world.”
For more information about this technology, visit NuVasive.
