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.
A routine, highly-predictive diagnostic test performed in a doctor’s office can help determine if you are a candidate for the Altius procedure. The test may provide hours or even days of pain relief.
A physician specializing in the treatment of amputees will temporarily numb the nerve causing your pain to determine if you are a candidate for the Altius procedure. The test usually takes about 30 minutes and can be done on the same day as your consultation. Patients who pass this simple diagnostic test have shown a high likelihood of successful results with Altius.
In the largest and most rigorous study1 ever done to assess the safety and effectiveness of a device for chronic post amputation pain in lower limb adult amputees, Altius was highly effective across a wide group of patients including:
The simple diagnostic test was highly predictive of successful results with Altius. Talk to your doctor about your condition.
Altius delivers electrical stimulation directly to damaged nerves. This helps prevent pain signals from reaching your brain, resulting in rapid and lasting pain relief.
With Altius, you are in control. Patients use a handheld controller about the size of a smartphone to start therapy and manage their pain on demand. You can watch a video about how therapy works here.
In the largest and most rigorous study1 ever done to assess the safety and effectiveness of a device for chronic post amputation pain in lower limb adult amputees, patients treated with Altius reported:
The Altius System is implanted during a minimally invasive procedure that typically lasts about one hour.
Patients typically go home the same day as the procedure and generally resume normal activities within 2-3 weeks, with guidance from their physician.
Once the incisions from your procedure are healed, you can expect to resume your normal activities. Your implant is unaffected by walking, bending over, and other normal daily activities.
Altius is an FDA PMA approved device, meaning the FDA has thoroughly reviewed extensive scientific evidence and determined Altius is safe and effective for its intended use. Only 1% – 5% of all medical devices in the U.S. meet the rigorous clinical data requirements to be FDA PMA approved.
In the largest and most rigorous study1 ever done to assess the safety and effectiveness of a device for chronic post amputation pain in lower limb adult amputees, no patients experienced unresolved safety issues related to the device or procedure.
Altius can be taken out in a simple outpatient procedure and does not limit the patient’s future treatment options.
The charging system uses a standard outlet and charging paddle placed over your IPG while you are seated. You can watch a video on how to charge the Altius system here.
At typical settings and usage, and with routine charging, the battery is predicted to last 10 years. If required, the IPG battery can be replaced during a simple outpatient procedure.
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.
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.
Insurance coverage varies by provider. With your permission, we may be able to work with insurance on your behalf to pursue approval in advance of the procedure. Our team has had good success in getting this covered for patients who show documented medical need. Email reimbursement@neurosmedical.com if you would like to speak with a member of our Patient Access Support Team about your individual plan.
* 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.
1. Kapural L, Kim B, Eidt J, et al. Long-term treatment of chronic post-amputation pain with bioelectric nerve block: 12-month results of the randomized, doubled-blinded, crossed-over QUEST study. Neuromodulation. 2024. 180 patients were enrolled in the clinical study. Individual patient outcomes may vary.
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.
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