Nevro Announces FDA Approval of its 10 kHz High Frequency Spinal Cord Stimulation Therapy for Treatment of Chronic Pain Associated with Painful Diabetic Neuropathy
This approval is specific to Nevro's unique 10 kHz stimulation, and Nevro now has the only spinal cord stimulation system approved by the FDA with a specific indication to treat PDN. The company will immediately initiate commercial launch activities in the U.S. under its recently launched HFX™ branding, as HFX™ for PDN.
Nevro Announces CE Mark Approval of Senza® Omnia™ Spinal Cord Stimulation System to Treat Chronic Pain
Omnia™ Spinal Cord Stimulation System is a completely new SCS platform and consists of a number of new components.
The Omnia system is the first and only SCS system designed to deliver Nevro's proprietary HF10® therapy in addition to all other available SCS frequencies.
Completion of Patient Enrollment in Largest Multicenter Randomized Controlled Trial of High Frequency Spinal Cord Stimulation for Painful Diabetic Neuropathy
The SENZA-PDN study compares HF10 therapy plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States.
Full-Body MRI Conditional Labeling Now Available in United States for Nevro Senza® Spinal Cord Stimulation System
3/23/18: This labeling expansion, which is now applicable in all our markets, adds to the previous labeling allowing head and extremity MRI scans, broadening the pool of patients who are eligible to receive the Senza SCS System.