Nevro, a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, announced that it has received CE Mark for expanded MR-conditional labeling.
The labeling expansion now permits the Senza spinal cord stimulation (SCS) system to be marketed in Europe and Australia for scans of the head and extremities with both 1.5 and 3 Tesla (T) 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 3T compatibility and extremities labeling is a significant advancement that provides HF10 therapy patients access to additional diagnostic tools," said Dr. Paul Verrills, President of the Australian & New Zealand Neuromodulation Society.
With the new MR-conditional labeling, Nevro is now the first company 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 geographies where Nevro currently sells the system commercially.
"We are pleased to offer even more imaging options for our patients. Nevro is a company that is continually looking to advance the SCS space, and this expanded MR-conditional labeling highlights our ongoing commitment to innovation," said Michael DeMane, Chairman and Chief Executive Officer of Nevro.
The Senza system is the only SCS system that delivers Nevro’s proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain.
The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered generator implanted under the skin.