Senza HF nerve stimulator for pain approved in 3T MRI scanners-Nevro
Nevro Corp has received European and Australian approval for its Senza spinal cord stimulator, designed to reduce pain, to be compatible, under specific conditions, with 3.0 Tesla MRI scanners. The device had previously been approved for scanning up to 1.5 Tesla. It is now the first spinal cord stimulator able to go into the strongest clinical MRI machines for scanning of patients’ head and extremities.
Comment: The device uses HF10 therapy which passes electrical pulses to the spine at 10kHz, at a far greater rate than conventional spinal cord stimulators. One advantage is a lack of paresthesia, a side effect of conventional stimulators. The system is yet to receive FDA approval, but it is under investigation in the SENZA-RCT prospective controlled trial. Positive data were reported in March 2014. In April 2014, Boston Scientific received FDA approval to launch its Precision Spectra device to treat chronic pain.