Nevro And Medtronic Announce FDA Approval Of Spinal Cord Stimulation Label Expansions
The FDA approved a diabetic peripheral neuropathy indication for Medtronic’s Intellis and Vanta spinal cord stimulators a few days after expanding the indication for Senza Nevro’s spinal cord stimulation system to include non-surgical refractory back pain.
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UnitedHealthcare will provide coverage for Nevro’s HFX spinal cord stimulation therapy for the treatment of painful diabetic neuropathy beginning on 1 March. Analysts believe the decision bodes well for the company’s chances of securing coverage from other insurers.
The FDA recently approved Nevro’s Senza high-frequency spinal cord stimulation systems to treat pain caused by diabetic neuropathy. Now it plans to expand its proprietary HFX high-frequency treatment to more indications.
A randomized trial demonstrated the superiority of Medtronic’s DTM spinal cord stimulation waveform over conventional spinal cord stimulation for treating back pain.