Nevro Gains FDA Approval for Senza System
Nevro has gained FDA 510(k) clearance for its Senza spinal cord stimulation system intended for chronic pain treatment, the Menlo Park, Calif., devicemaker announced last week.
The device administers the company’s HF10 therapy in the trunk and/or limbs, which treats unilateral or bilateral pain related to failed back surgery, intractable low back pain and leg pain.
HF10 therapy works by delivering electrical pulses to the spinal cord.
The therapy is the only SCS therapy FDA-indicated to alleviate pain without paresthesia (a constant tingling sensation associated with traditional SCS techniques), and is the first therapy of its kind to demonstrate superior efficacy to traditional SCS therapy in a comparative study, the devicemaker claims.
The Senza system is available in Europe and Australia. — Jason Scott