NuVasive, Inc. has received some good news from the government…now life can be less painful for pediatric spinal deformity patients. According to the October 27, 2016 news release, the company has obtained “FDA clearance for magnetic resonance imaging (MRI) under certain conditions on patients treated with the innovative MAGEC system…”
Conditional FDA Clearance for Certain MRIs On MAGEC Patients
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“MAGEC is comprised of a sterile, single use spinal rod that is surgically implanted to brace the spine during growth and includes a small internal magnet that is controlled by an external remote controller. Periodic lengthening of the rod is performed to follow the growth of the spine, and can be performed external to the body in an office setting. The magnetic technology helps eliminate traditional planned distraction surgeries and simplifies care for the EOS [early onset scoliosis] patient population.”
“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.”
“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.”
Dr. Shah told OTW, “There was limited data on MRI safety with MAGEC prior to the FDA clearance. Patient safety and the possibility that the magnetic implant could be damaged from interactions between the magnet rod and the MRI machine were some of the initial concerns. The clearance provides clear instructions to follow so that these concerns are minimized.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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