Nevro’s Spinal Cord Stimulation System Gets FDA Approvable Nod

California devicemaker Nevro received an approvable letter from the FDA for its Senza spinal cord stimulation system. Final approval is subject to a successful inspection and audit of its manufacturing facilities and finalization of product labeling, the Menlo Park, Calif., company said Thursday.

The Senza system delivers electrical pulses to the spinal cord to alleviate pain. Small electrodes on leads are placed near the spine and connect to a small, battery-powered generator implanted under the skin. Studies have shown the therapy provides pain relief without the tingling sensation that can occur in traditional stimulation therapy, Nevro said.

CEO Michael DeMane said the company is working to satisfy the conditions of approval and hopes to launch the system in the U.S. market by mid-year.

The Senza system is currently available in Europe and Australia, where over 2,500 patients have been treated, Nevro said. — Kellen Owings