Nevro Corp, a medical device company that has developed and commercialised an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, announced that it has received a letter from the US Food and Drug Administration (FDA) informing the company of the approvability of its Premarket Approval Application (PMA) for the Senza spinal cord stimulation (SCS) system. According to the approvable letter, approval of the PMA is subject to satisfaction of regulatory inspections and audits of manufacturing facilities, methods and controls for Senza to ensure compliance with the FDA's Quality System Regulation, as well as finalisation of the product's labelling with the FDA.
"We are pleased that the FDA has determined our Senza SCS system to be approvable based on the strength of the data provided in the PMA. We are working to satisfy the conditions of approval and anticipate initial commercial availability in the U.S. by mid-2015", said Michael DeMane, Chairman and Chief Executive Officer of Nevro. "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."
Dr. Leonardo Kapural, the lead investigator of the SENZA-RCT study, presented the study results at the Groundbreaking Clinical Trial Results plenary session of the 2014 North American Neuromodulation Society Meeting in December. The Senza system is commercially available in Europe and Australia where over 2,500 patients have been treated to date.
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. As demonstrated in the SENZA-RCT study, HF10 therapy provides pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS therapy).