The FDA cleared magnetic resonance imaging for certain conditions on patients treated with NuVasive's MAGEC system.
Here are five insights:
1. Since early onset scoliosis patients often require many MRIs, the lack of guidance on MR conditions served as a barrier to MAGEC adoption.
2. The FDA clearance encompasses MR conditions using a "1.5 Tesla Static Magnetic Field MRI machine at a maximum spatial field gradient of 3000 gauss/cm with a maximum MR System reported, whole body averaged specific absorption rate of 0.5 W/kg at 1.5T."
3. The MAGEC system should not exceed a maximum temperature rise of more than 3.7 degrees Celsius after 15 minutes of continuous scanning.
4. MAGEC represents the sole FDA-cleared noninvasive solution for growth modulation in pediatric spinal deformity.
5. The MAGEC technology includes a single-use spinal rod that is surgically implanted to brace the spine during growth. Equipped with an internal magnet, surgeons may extend the rod via an external controller as the patient grows.