Nevro has received CE mark for expanded MR-conditional labelling. The labelling expansion now permits the Senza spinal cord stimulation system to be marketed in Europe and Australia for scans of the head and extremities with both 1.5 and 3 Tesla MRI machines under specified conditions for existing and future patients.
“Spinal cord stimulation is an important tool in treating chronic pain, and the addition of 3 Tesla compatibility and extremities labelling is a significant advancement that provides HF10 therapy patients access to additional diagnostic tools,” said Paul Verrills, president of the Australian and New Zealand Neuromodulation Society.
With the new MR-conditional labelling, Nevro is now the first company to offer MRI compatibility with 3 Tesla machines for an implantable spinal cord stimulation system. The new labelling includes all generations of the Senza system dating back to 2010 and applies to all geographies where Nevro currently sells the system commercially.