09.05.2015 04:53:44

Nevro Gets FDA Approval For Senza Spinal Cord Stimulation System - Quick Facts

(RTTNews) - Nevro Corp. (NVRO) announced that it has received approval from the U.S. FDA for its Senza spinal cord stimulation system. The Senza SCS system, which delivers 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.

The company noted that the labeling for the Senza system and HF10 therapy was based on the SENZA-RCT clinical trial, where HF10 therapy was meaningfully superior to traditional SCS therapy for back and leg pain, including superior response rates, pain relief, and functional outcomes.

Nevro also announced that it will now be releasing financial results for the first quarter of 2015 before market open on Monday, May 11, 2015.

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