Nevro Corp. (NYSE:NVRO) said it won pre-market approval from the FDA for new surgical leads designed to be used with its Senza spinal cord stimulation device.
The Senza device, which won an FDA nod in May 2015, is designed to deliver high-frequency electrical impulses of up to 10,000Hz to the spinal cord to avoid the tingling sensation known as paresthesia that bothers some SCS patients. The FDA approval allows Redwood City, Calif.-based Nevro to label the device’s HF10 therapy \ as superior to conventional spinal cord stimulators.