Nalu Medical, Inc.
Product Safety Information - Brief Summary
Prior to using these devices, please review the latest Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.
Indications for use:
Spinal Cord Stimulation - The Nalu Neurostimulation System is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Peripheral Nerve Stimulation - The Nalu Neurostimulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
Contraindications: Patients contraindicated for this therapy are those who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, and/or are pregnant.
General Warnings, Precautions, Adverse Events: Please refer to the latest Instructions for Use provided with the Nalu Neurostimulation System for warnings, precautions, and potential adverse events prior to using the system.
