Question & Answer
The Altius Direct Electrical Nerve Stimulation System is FDA-approved to help adults living with lower limb loss who have chronic post-amputation pain, such as phantom limb pain and residual limb pain.
Altius delivers electrical stimulation directly to damaged nerves. This helps prevent pain signals from reaching your brain, resulting in rapid and lasting pain relief.
Patients use a handheld Patient Controller the size of a smartphone to activate the Altius® system and manage pain on demand.
In a clinical study, patients treated with the Altius System reported:
- 50% reduction in pain*
- 45% improvement in quality of life
- Significant decrease or total elimination in opioid use
Altius can be implanted by a trained surgeon, typically as a same-day procedure under general anesthesia.
Some pain at the incision sites is normal and should improve within a few days. Patients can typically return to normal activities within 2-3 weeks. Recovery length may depend on amputation type, prosthetic use, and level of activity before surgery. Your doctor will provide specific instructions on post-op medications, incision care, and when to resume activities.
Once the incisions from your surgery are healed, you can expect to resume your normal activities. Your implant is unaffected by walking, bending over, and other normal daily activities.
At typical settings and usage, and with routine charging, the battery is predicted to last 10 years. The charging system uses a standard outlet and charging paddle placed over your IPG while you are seated.
If required, your surgeon can replace your IPG during a simple outpatient procedure.
Insurance coverage varies by provider. Neuros Medical can provide resources to providers and patients regarding access to treatment with the Altius system.
Safety of MRI testing with an implanted Altius system has not been evaluated. Patients implanted with the Altius system, or any of its components, should not undergo MRI testing.
Yes. Prior to passing through airport security systems, patients should notify the attendant security personnel that they carry an implant and should present their implant ID card. You can request screening by Advanced Imaging Technology (AIT) or a manual procedure (e.g. pat down) as alternatives to metal detectors.
It’s Time to Take Control Over the Pain
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Contact Us* Patients in the clinical study started therapy with Altius upon feeling pain. Patients averaged ~30% reduction in pain 30 minutes after starting a session and ~50% reduction in pain 120 minutes after starting a session.
Indications for Use: The Altius® Direct Electrical Nerve Stimulation System is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Contraindications: The Altius system is contraindicated for patients who are: Unable to operate the system or Unsuitable for the Altius implant surgery. Warnings/Precautions: Use as indicated and instructed. Diathermy should not be used on patients with the Altius System, or any of its components, either as a treatment for a medical condition or as part of a surgical procedure. Electromagnetic interference (EMI) is a field of energy generated by equipment found in the home, work, medical, or public environments that is strong enough to interfere with Altius system function. The electrical pulses from the Altius system may interact with the sensing operation from a cardiac device and could result in an inappropriate response of the cardiac device; physicians involved should discuss the possible interactions between the devices before surgery. Safety and Effectiveness of Altius System for pediatric use and for pregnant patients has not been established. Surgical complications and adverse events may be more frequent and severe in diabetic patients. Safety of MRI/NMRI with an implanted Altius system has not been evaluated. Patients implanted with the Altius System, or any of its components, should not be subject to MRI/NMRI. See Instructions for Use for detailed information regarding the procedure(s), indications, contraindications, warnings, precautions, and potential adverse events. For further information and to view full Instructions for Use, visit www.neurosmedical.com.
Although FDA has determined that the probable benefits outweigh the probable risks, there remains some uncertainty regarding the manufacturer’s human factors engineering (HFE) and usability engineering (UE) analysis and validation testing. As a condition of approval, FDA is requiring the manufacturer to provide an HFE/UE analysis and validation testing and recommending that this analysis and testing is designed using the FDA’s 2016 guidance document “Applying Human Factors and Usability Engineering to Medical Devices” (https://www.fda.gov/media/80481/download).
This information is for informational purposes only, is not medical advice or a diagnosis, and is not a substitute for professional medical advice. Consult with your doctor regarding your condition. Individual symptoms, circumstances, and results vary.