Methods for providing ventricular support for a human patient

A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure, the method comprising:

• inserting a mechanical circulatory support device into the vasculature of a human patient, the mechanical circulatory support device being movable between a compressed state having an outer diameter of approximately 9 French (Fr) and an expanded state having an outer diameter of approximately 21 Fr;
• delivering, with the aid of a delivery assist device, the mechanical circulatory support device into a heart of the human patient, while in the compressed state;
• operating the mechanical circulatory support device for a support period at up to a maximum flow rate of approximately 4.4 L/min, while in the expanded state;
• and
• achieving a risk of a clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.