Innovative Spinal Stimulator OK’d

A medical device that, according to its manufacturer, Nevro Corp., eliminates the side effects of spinal stimulation, has received Food and Drug Administration approval. Nevro officials say that their Senza System is the only device in the class that does not produce a tingling sensation known as paresthesia.

Varun Saxena, writing for Fierce Medical Devices, reports that Nevro’s Senza System fights chronic pain in the back and legs without causing unwanted side effects. It does this “by delivering high frequency stimulation at 10 kilohertz and low amplitudes.” The system was tested in a 198 person randomized, controlled clinical trial. Company officials report that Senza patients had better outcomes than those on traditional simulators, as measured by response rates, pain relief and functional outcomes.

“My fellow investigators and I have eagerly awaited the approval of the Senza SCS system, ” said the trial’s lead investigator, Leonardo Kapura, M.D., of Wake Forest University Baptist Medical Center, in the press release. “The results of the study showed that HF10 therapy provides better pain relief and nearly twice the response rate of traditional SCS, representing a tangible advance in chronic pain management. HF10 therapy will allow me to help more patients in my practice by addressing back pain in addition to leg pain. And, with HF10 therapy, I can for the first time focus on providing pain relief to my patients instead of managing paresthesia, which is a paradigm shift for my pain practice.”

Saxena wrote that “the device consists of leads inserted into the back that connect to a pulse generator…implanted in the patient’s buttocks region or abdomen. The pulse generator is programmed prior to implantation, and controlled externally via remote following the procedure.”

In its press release Nevro claimed that the Senza is the only spinal cord stimulator approved without restrictions on driving while receiving therapy and also “the only one to receive labeling for 3 Tesla conditional MRI compatibility.” Senza has been available in the European Union and Australia over the past five years. “With PMA approval and the first FDA SCS superiority label, these meaningful patient benefits will for the first time be made available to U.S. chronic pain patients, ” said Michael DeMane, CEO of Nevro in a statement.