Electrical Nerve Block for Amputation Pain

The Altius System is an implanted device designed to electrically block nerve signals and
alleviate pain. Use of this device may be associated with providing an effective,
mechanism-based yet non-destructive, treatment for managing intractable limb pain in
amputees. In a given patient, the Altius System will be deemed effective if treatment results
in 50% reduction of pain score for more than 50% of all pain episodes.

Key Inclusion Criteria:

- Age ≥ 21 years old

- Unilateral amputated leg ≥ 12 months

- Chronic post amputation pain ≥ 6 months

- Pain episodes typically lasting ≥ 60 minutes

- Stable drug regimen ≥ 6 weeks

- No changes to medications or prosthesis for 3-month primary study period

Key Exclusion Criteria:

- Implanted with an active implantable medical device (i.e. pacemaker)

- Confounding source of pain that interferes with reporting of limb pain

- Uncontrolled diabetes

- Spasticity preventing full range of motion of involved side

- Extremely short stump; sits on end

- Untreated psychological condition (i.e. borderline personality)

- Condition requiring MRI studies or diathermy after device implant

- Life expectance of less than 24 months

- Progressive neurological disease (i.e. multiple sclerosis)