LivaNova, a company with offices in Texas and Belgium that makes vagus nerve stimulation (VNS) systems that help to prevent the onset of epileptic seizures, received FDA approval for patients with the implants to be free to undergo MRI scans. While some precautions are still necessary, the previous MRI related approval required special equipment to be used during scans that is rarely available. The new approval essentially means that patients should be able to safely receive MRI scans at any imaging facility, greatly expanding the diagnostic options for people that have a high chance of requiring imaging in the future.
“The FDA’s approval to expand our MRI labeling changes the landscape for device-based epilepsy therapies,” in a statement said Jason Richey, LivaNova’s President of North America & General Manager of the Neuromodulation franchise. “This further differentiates our technology from other epilepsy treatment options and adds a new dimension in our ability to support patients’ long-term treatment plans.”
Flashback: AspireHC Vagus Nerve Stimulator Cleared in U.S. Market…
Link: LivaNova VNS Therapy info page…
Via: LivaNova…