Nevro Corporation has earned the CE Mark for expanded MR-conditional labeling, permitting the company’s Senza spinal cord stimulation (SCS) system to be marketed in Europe and Australia. The MR-conditional labeling allows the Senza SCS to be used for scans of the head and extremities with both 1.5T and 3T MRI machines under specified conditions. Senza is the first implantable spinal cord stimulation system compatible with 3T magnetic resolution imaging (MRI), according to the company.
“Spinal cord stimulation is an important tool in treating chronic pain, and the addition of 3T MRI compatibility and extremities labeling is a significant advancement that provides HF10 therapy patients access to additional diagnostic tools,” said Paul Verrills, MD, president of the Australian and New Zealand Neuromodulation Society.
According to Nevro, the new MR-conditional labeling makes the company the first to offer MRI compatibility with 3T machines for an implantable SCS system. The new labeling includes all generations of the Senza SCS system dating back to 2010, and applies to all geographical locations where the Nevro system is currently sold commercially.
More information about the Senza spinal cord stimulation (SCS) system is available on the Nevro website.