CS1-004 will be an extension of the CS1-003 Study. The primary objective of the CS1-004 study is to evaluate long-term safety and tolerability of continued treatment with CS1.
Patient has derived benefit from CS1 treatment in parent Study CS1-003 based on the Investigator's judgement and the benefit of continued CS1 treatment outweighs the risk or the patient could benefit from continued treatment with CS1.
Patient must be willing and able to sign a written informed consent prior to any study-related procedures and able to understand and follow instructions; return to the study unit for specified study visits; and able to participate in the study for the entire period.
Patient is classified as New York Heart Association/World Health Organisation (NYHA/WHO) functional Class I, II or III.
Patient has CardioMEMS PA Sensor implanted and has completed treatment per parent protocol in Phase 2 Study CS1-003.
Patient has a concomitant medical disorder that is expected to limit the patient's life-expectancy to ≤1 year.
Patient has thrombocytopenia: platelets <100,000/mm3.
Patient has a recent history of pancreatic disease.
Patient is a pregnant or lactating female.