FDA Approves Senza®, Nevro’s High Frequency Spinal Cord Stimulation Therapy For PDN
On July 19, 2021, Nevro Corp, a global medical device company, announced the U.S. Food and Drug Administration ((FDA) approval of its Senza® System, specifically Nevro’s 10 kHz stimulation for the treatment of chronic pain associated with painful diabetic neuropathy (PDN)–a type of nerve damage associated with diabetes that affects the legs and feet. The Senza system is the only spinal cord stimulation system approved by the FDA and had been previously approved for other disease states and issues including back pain.
The efficacy of Senza was determined in a randomized control trial that included 216 patients with PDN for one year or more and at least one other lower limb pain. Participants were recruited from multiple sites across the U.S., including academic centers and community pain clinics between August 2017 and August 2019.
The study compared conventional medical management (CMM) to 10 kHz SCS plus CMM. Pain was measured using a visual analog scale (VAS), a tool to measure pain. With a VAS, patients are asked to share their perceived pain intensity along a horizontal line. The rating is measured and is known as the VAS score. A higher score means greater intensity.
For the CMM group, the mean VAS score was 7.6 cm prior to the intervention. At six months, the pain was reduced to 1.7 cm. Investigators observed neurological improvements in 52 of 84 participants (62 percent) in the 10-kHz SCS plus CMM group at six months compared to 3 of 92 participants (3 percent) in the CMM group.
Overall, the trial showed that the 10-kHz SCS can give substantial pain relief and improve quality of life over six months.
“Diabetic neuropathy is one of the most prevalent and debilitating, chronic complication of diabetes, and for years, PDN patients have struggled with a lack of effective treatment options when conventional medications fail or are not tolerated,” commented Dr. Frances Broyles, medical director of Diabetes/Endocrinology and Nutrition at Swedish Health Services in Seattle, Washington.
“The ability to now offer Nevro’s proven 10 kHz Therapy, which may enable discontinuation of long-term drug therapy and eliminate unwanted drug side effects, is a welcome addition as a treatment option for my PDN patients dealing with this challenging condition.”
Nevro Corp plans to commercialize the therapy immediately in the U.S. with launches in the UK, Germany and AUS commencing earlier this year in 2021.