FDA approves Senza SCS System for Chronic Pain- Nevro Corp

The FDA has given marketing approval for the Senza spinal cord stimulation (SCS) system, from Nevro Corp, for Chronic Pain. The Senza SCS system, which delivers Nevro's proprietary HF10 therapy, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

Approval is based on the SENZA-RCT pivotal study, a study that was the first to directly compare SCS therapies. The multicenter study was conducted across 11 US clinical trial sites, comparing the safety and effectiveness of HF10 therapy to traditional SCS therapy. The study enrolled 241 patients, making it the largest prospective randomized SCS study ever conducted to assess the treatment of chronic back and leg pain. After two years of HF10 therapy, the mean baseline back pain score of 8.4 out of 10.0 was reduced to 3.3. The mean baseline leg pain score of 5.4 out of 10.0 was reduced to 2.3.

Comment: The device is approved in the EU and Australia. The system is: the only SCS therapy indicated by FDA to deliver pain relief without paresthesia (a constant tingling sensation that is the basis of traditional SCS); the only SCS therapy approved by FDA to be used without patient restrictions on motor vehicle operation while receiving therapy; and the only implantable SCS system approved by FDA with labeling for 3T conditional MRI compatibility. Competing devices are in development by Boston Scientific and Medtronic.