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FDA approves Senza Spinal Cord Stimulation System

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The FDA recently announced the premarket approval of Nevro Corporation’s Senza Spinal Cord Stimulation System. The new system can now begin commercial distribution, according to a letter from the FDA to the company.

The implanted, rechargeable spinal cord stimulation system is designed for the treatment of chronic pain of the trunk and/or limbs that is difficult to manage, according to an FDA release. It can deliver high-frequency stimulation (10 kHz) that, in combination with low-stimulation amplitudes, cannot be felt by the patient. The system receives a radio signal from a controller used by the patient or surgeon, which tells the system when and how to deliver appropriate electrical stimulation.

According to the FDA, failure to comply with any post-approval requirement constitutes grounds for the withdrawal of approval of the premarket approval application.

Expiration dating for this device has been established and approved at 3 years, according to the press release.

Reference: www.fda.gov.