- amputation due to atherosclerotic disease. Subject may be of either sex and of any race, and must be >18 years of age. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 4 months during the study period Subject must be willing and able to give appropriate informed consent. The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).