NuVasive (NUVA) Receives FDA Clearance for MRI for MAGEC System Under Certain Conditions
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NuVasive, Inc. (Nasdaq: NUVA) announced FDA clearance for magnetic resonance imaging (MRI) under certain conditions on patients treated with the innovative MAGEC system. MAGEC is the only noninvasive solution for growth modulation in pediatric spinal deformity cleared by the FDA.
Early onset scoliosis (EOS) patients often suffer from comorbidities which makes their treatment complex and often requires them to undergo multiple MRIs. The lack of guidance on MR conditions was historically a hurdle for some surgeons in widely adopting MAGEC as a treatment option for their EOS patients.
"Having clear, defined guidance for conditional MRI compatibility with MAGEC helps alleviate uncertainty that may have limited surgeons from using the innovative MAGEC system," said Suken A. Shah, M.D., Division Chief of the Spine and Scoliosis Center, Clinical Fellowship Director, Nemours/Alfred I. duPont Hospital for Children. "This clearance opens up the door for more patients and their families to benefit from this life changing technology."
The clearance includes MR conditions using 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 specific absorption rate (SAR) of 0.5 W/kg at 1.5T. Under the scan conditions defined, the MAGEC System is expected to produce a maximum temperature rise of no more than 3.7 degrees Celsius after 15 minutes of continuous scanning. The 1.5 T MRI machine is the global standard. The complete MRI safety information is included in the product labeling.
"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 EOS," said Jason Hannon, NuVasive's president and chief operating officer. "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."
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