This is a Humanitarian Use Device study. A Humanitarian Use Device is a medical device intended to benefit patients in treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals per year in the United States. This consent and authorization form explains why this HUD study is being done and what your role will be if you choose to take part. This form also describes the possible risks connected with being in this study. After reviewing this information with the person responsible for your enrollment, you should know enough to be able to make an informed decision on whether you want to take part in the study. You may choose not to take part in this study