Nevro 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 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 working to satisfy the conditions of approval and anticipate initial commercial availability in the USA by mid-2015″, said Michael DeMane, chairman and chief executive officer of Nevro.
Leonardo Kapural, the lead investigator of the SENZA-RCT study, presented the study results at the Groundbreaking Clinical Trial Results plenary session of the recent North American Neuromodulation Society Meeting (11–14 December, 2014, Las Vegas, USA). The Senza system is commercially available in Europe and Australia where over 2,500 patients have been treated to date.