 This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. The Data Safety Monitoring Committee DSMC will review all complications and recommend whether it is safe to proceed to the CE Mark study. All patients will continue to be followed at 1, 3 and 12 month follow-ups. 