Medical device company Nevro has obtained approval from the US Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS) system.
FDA has approved the firm’s Premarket Approval Application (PMA) for the system, subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza.
Nevro chairman and CEO Michael DeMane said: "We are working to satisfy the conditions of approval and anticipate initial commercial availability in the US by mid-2015.
"I would like to thank everyone involved in our SENZA-RCT study, especially the investigators, study coordinators, Nevro employees, and most importantly the patients who consented to participate in the first ever comparative, prospective randomized pivotal trial in the history of spinal cord stimulation."
The Senza system delivers the firm’s proprietary HF10 therapy, which provides electrical pulses to the spinal cord to relieve pain.
Small electrodes placed near the spinal cord that are connected to a battery-powered generator implanted under the skin are said to generate electrical pulses.
HF10 therapy provides pain relief without paresthesia, as demonstrated in the SENZA-RCT study, noted Nevro.
The Senza system is limited by federal law to investigational use only, in the US.