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With approval announced on July 19, HFX becomes the only spinal cord stimulation therapy approved by the FDA with a specific indication for painful diabetic neuropathy.
The US Food and Drug Administration has approved the Senza System from Nevro Corp. for the treatment of chronic pain associated with painful diabetic neuropathy, according to a release from Nevro Corp.
With approval, the 10 kHz high frequency spinal cord stimulation therapy, which Nevro will market as HFX(TM) , becomes the only spinal cord stimulation system approved by the FDA with a specific indication for painful diabetic neuropathy.
"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," said Frances Broyles, MD, 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. My personal practice experience with the Nevro 10 kHz Therapy was nothing short of life changing for the patient."
Approval of the therapy is based on the results of the SENZA-PDN trial, which demonstrated use of the system was associated with significant improvements in quality of life and substantial, sustained pain relief. A 216-person trial assessing use of the system versus standard medical management, 6- and 12-month results of SENZA-PDN were published in JAMA Neurology and presented at ADA 2021, respectively.
In the trial, 82% of patients randomized to standard medical management opted to crossover to HFX. At 12 months, results indicated patients using the system experienced clear, sustained benefits in regard to lower limb pain, pain interference with daily living, sleep quality, and activity. The statement from Nevro Corp. noted plans to publish the 12-month results in a peer-reviewed journal and also pointed out plans to continue the study out to 24 months.
"This FDA approval marks a capstone achievement that demonstrates the strength of our clinical data and provides a proven, new breakthrough SCS treatment option for PDN patients who are struggling with debilitating pain and who are unable to find relief with currently available pharmacologic options," said D. Keith Grossman, Chairman, Chief Executive Officer and President of Nevro. "We are thrilled that we can now begin commercial launch activities in the U.S. and believe this new indication will be an important driver of the long-term growth of our business for years to come."
For more on SENZA-PDN, check out our coverage of results from ADA 2021.